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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.
The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced OSCC. And on this basis, we will explore the changes of the profiles and functions of immune cells within tumors, lymph nodes and peripheral blood after the experimental interventions, as well as their correlation with the patients' response and prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant PD-1 blockade alone | Experimental | The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. |
|
| Neoadjuvant PD-1 blockade plus TPF induction chemotherapy | Experimental | The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Response. | Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy. Hematoxylin and eosin (H&E)-stained slides of entire tumor and all sampled lymph nodes were scanned and assessed by two independent pathologists. The entire tumor bed and all sampled lymph nodes were examined histologically in patients who had pathological complete response (pCR), which was defined as the absence of viable tumor in all slides. MPR was defined as the presence of 10% or less viable residual tumor in the resected tumor specimens. Pathological partial response (pPR) was defined as presence of more than 10% and less than 50% viable residual tumor and pathological non-response (pNR) was defined as presence of more than 50% viable residual tumor in the resected tumor specimens. Pathologic response was defined as sum of pCR and MPR. | 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Response. | Radiographic response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy were evaluated by enhanced computed tomography examinations and defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete Response (CR) was defined as disappearance of all target lesions. Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions. Stable disease (SD) was defined as <20% increase and <30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) was defined as >=20% increase in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Level of Circualting Exosomal PD-L1. | The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA). | 24 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Chen, MD | Hospital of Stomatology, Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Stomatology, Wuhan University | Wuhan | Hubei | 430079 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40107247 | Derived | Liu YT, Liu HM, Ren JG, Zhang W, Wang XX, Yu ZL, Fu QY, Xiong XP, Jia J, Liu B, Chen G. Immune-featured stromal niches associate with response to neoadjuvant immunotherapy in oral squamous cell carcinoma. Cell Rep Med. 2025 Mar 18;6(3):102024. doi: 10.1016/j.xcrm.2025.102024. | |
| 39889711 | Derived | Liu HM, Xiong XP, Yu ZL, Shao Z, Chen GL, Liu YT, Wang XX, Fu QY, Cheng XX, Li J, Zhang JL, Li B, Gong HY, Zhong YH, Zhang W, Jia J, Liu B, Chen G. Neoadjuvant immunotherapy with or without chemotherapy in locally advanced oral squamous cell carcinoma: Randomized, two-arm, phase 2 trial. Cell Rep Med. 2025 Feb 18;6(2):101930. doi: 10.1016/j.xcrm.2025.101930. Epub 2025 Jan 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant PD-1 Blockade Alone | The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery. |
| FG001 | Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy | The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant PD-1 Blockade Alone | The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Response. | Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy. Hematoxylin and eosin (H&E)-stained slides of entire tumor and all sampled lymph nodes were scanned and assessed by two independent pathologists. The entire tumor bed and all sampled lymph nodes were examined histologically in patients who had pathological complete response (pCR), which was defined as the absence of viable tumor in all slides. MPR was defined as the presence of 10% or less viable residual tumor in the resected tumor specimens. Pathological partial response (pPR) was defined as presence of more than 10% and less than 50% viable residual tumor and pathological non-response (pNR) was defined as presence of more than 50% viable residual tumor in the resected tumor specimens. Pathologic response was defined as sum of pCR and MPR. | Posted | Count of Participants | Participants | 8 weeks. |
|
The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant PD-1 Blockade Alone | The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reactive cutaneous capillary endothelial proliferation, RCCEP | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gang Chen, MD | Hospital of Stomatology, Wuhan university | +86 02787686215 | geraldchan@whu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 25, 2022 | Aug 17, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Camrelizumanb plus TPF | Drug | The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles. |
|
|
| 8 weeks. |
| Event-free Survival (EFS) Rate on Each Treatment Arm. | EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1. | 24 months. |
| Overall Survival (OS) on Each Treatment Arm. | OS is the time from randomization to death due to any cause. | 24 months. |
| Adverse Events (AEs). | Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions. | 24 months. |
| BG001 |
| Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy |
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tumor site | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| Alcohol use history | Count of Participants | Participants |
|
| Clinical T-stage | Classification of patients of oral squamous cell carcinoma based on T stage | Count of Participants | Participants |
|
| Clinical N-stage | Classification of patients of oral squamous cell carcinoma based on N stage | Count of Participants | Participants |
|
| PD-L1 combined positive score | The expression of programmed cell death-ligand 1 (PD-L1) in patients was carried out using immunohistochemical staining. Combined positive score (CPS) of PD-L1 was defined as the total number of PD-L1-stained cells (including tumor cells, tumor-associated lymphocytes, and macrophages) divided by the total number of viable tumor cells, multiplied by 100. The range was from 0-100. PD-L1>1 was considered as cut-off value for derermine positive expression of PD-L1 in oral squamous cell carcinoma. | Count of Participants | Participants |
|
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery. |
| OG001 | Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy | The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles. |
|
|
| Secondary | Radiographic Response. | Radiographic response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy were evaluated by enhanced computed tomography examinations and defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete Response (CR) was defined as disappearance of all target lesions. Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions. Stable disease (SD) was defined as <20% increase and <30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) was defined as >=20% increase in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. | Posted | Count of Participants | Participants | 8 weeks. |
|
|
|
| Secondary | Event-free Survival (EFS) Rate on Each Treatment Arm. | EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1. | Not Posted | 24 months. | Participants |
| Secondary | Overall Survival (OS) on Each Treatment Arm. | OS is the time from randomization to death due to any cause. | Not Posted | 24 months. | Participants |
| Secondary | Adverse Events (AEs). | Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions. | Not Posted | 24 months. | Participants |
| Other Pre-specified | Changes in the Level of Circualting Exosomal PD-L1. | The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA). | Not Posted | 24 months. | Participants |
| 0 |
| 34 |
| 2 |
| 34 |
| 34 |
| 34 |
| EG001 | Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy | The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles. | 1 | 34 | 11 | 34 | 34 | 34 |
| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| White blood cell decreased | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatine kinase increased | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatinine increased | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Mucositis oral | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatinine increased | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| GGT increased | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| ALT increased | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| AST increased | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatine kinase increased | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| SD (Stable disease) |
|
| PD (Progressive disease) |
|
| Non-evaluable |
|