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To determine the Efficacy and Safety of camrelizumab and apatinib combined with chemotherapy (mFOLFOX6) for MSS/pMMR locally advanced colon cancer.
To determine the rate of tumor regression grade 2-4 at time of radical resection of MSS/pMMR colon cancer following neoadjuvant treatment.To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment, pathologic complete response (pCR) rates, R0 resection rate, 2 year Disease free survival, OS(overall survival) and adverse events, including perioperative complication and mortality rate.
To determine the pathologic downstage rates and pCR rate of radical resection of MSI/dMMR colon cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy, PD-1 inhibitor and Apatinib | Experimental | Participants received 5 preoperative cycles of PD-1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery. Apatinib,PD-1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab , apatinib and chemotherapy | Drug | Camrelizumab 200 mg, IV infusion on Days 1 each 14-day cycle Apatinib 250mg oral administration once a day, for two months mFOLFOX6 oxaliplatin 85 mg/m^2 IV infusion on Day 1 of each14-day cycle. Fluorouracil: 400 mg/m2 as a bolus injection given after a two-hour leucovorin infusion at a dose of 400 mg/m2. The loading dose is then followed by a 46-hour 5-fluorouracil infusion of 2,400 mg/m2 via a pump programmed to provide a constant drug infusion rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Regression Rate of MSS/pMMR Patients | the percentage of tumor regression rate (2-4) in pMMR patients | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) Rates | Percentage of patients with pathological complete response | 2 years |
| R0 Resection Rate | R0 resection accounted for the percentage of all surgical patients=100% |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital, Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41922688 | Derived | Tong Z, Gao L, Wang D, Zhao P, Bao X, Zhang H, Dai X, Liu L, Zhu X, Gao Y, Zheng Y, Fu Q, Liu F, Chen W, Xu X, Fang W. Neoadjuvant mFOLFOX6 plus camrelizumab and apatinib in colon cancer and biomarker research via spatiotemporal-omics profiling. NPJ Precis Oncol. 2026 Apr 1;10(1):192. doi: 10.1038/s41698-026-01387-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy, PD-1 Inhibitor and Apatinib | Participants received 5 preoperative cycles of PD-1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery. Apatinib,PD-1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy. Camrelizumab , apatinib and chemotherapy: Camrelizumab 200 mg, IV infusion on Days 1 each 14-day cycle Apatinib 250mg oral administration once a day, for two months mFOLFOX6 oxaliplatin 85 mg/m^2 IV infusion on Day 1 of each14-day cycle. Fluorouracil: 400 mg/m2 as a bolus injection given after a two-hour leucovorin infusion at a dose of 400 mg/m2. The loading dose is then followed by a 46-hour 5-fluorouracil infusion of 2,400 mg/m2 via a pump programmed to provide a constant drug infusion rate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy, PD-1 Inhibitor and Apatinib | From January 2021 to September 2022, 12 patients were enrolled. Most (10 [83.3%] of 12) patients were female. There were 10 patients (83.3%) with right-sided colon cancer. 7(58.3%) had cT4 stage tumors, and all patients had positive lymph nodes on baseline radiographic assessment. 10 (83.3%) completed the planned cycles of neoadjuvant therapy. 1 patient received 3 cycles of neoadjuvant therapy as a serious adverse event and 1 patient received 2 cycles of neoadjuvant therapy as tumor perforation . Of the 12 patients, 11 underwent surgery, of whom R0 resection was performed and 1 refused |
| 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 | Tumor Regression Rate of MSS/pMMR Patients | the percentage of tumor regression rate (2-4) in pMMR patients | Posted | Count of Participants | Participants | 2 years |
|
|
2 year
Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
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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 | Neutropenia | the most common adverse events were neutropenia (83.3%) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weijia Fang | The First Affiliated Hospital, Zhejiang University School of Medicine | +86 87235147 | weijiafang@zju.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 7, 2021 | May 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2021 | May 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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MSS/pMMR:Participants received 5 preoperative cycles of PD1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery.
Apatinib,PD1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy.
MSI/dMMR:Participants received 5 preoperative cycles of PD1 inhibitor and 2 months of apatinib, followed by surgery.
Apatinib,PD1 inhibitor needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of PD-1 monoclonal antibody and apatinib were performed as adjuvant therapy.
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|
| 2 years |
| The Rate of 2 Year Disease Free Survival (DFS) | Disease-free survival (DFS) is defined as the time from operation to recurrence of tumor or death. We will evaluate 2 year DFS is 100% | 2 years |
| Overall Survival (OS) | Refers to the time of death from enrollment to any cause | 2 years |
| Event Free Survival (EFS) | The period from the beginning of neoadjuvant therapy to the occurrence of any of the following events, whichever occurs first: tumor progression as assessed by RECIST 1.1; Tumor recurrence, including local recurrence or distant metastasis; Death from any cause; EFS=100% | 2 years |
| Perioperative Complication Rate | The complication rate of all patients during the period around the time of a surgical operation | 3 months |
| Mortality Rate | the ratio between deaths and all patients in the study during treatment | 2 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ECOG performance status | Eastern Cooperative Oncology Group performance status (ECOG PS) :The scale ranges from 0 to 5, with lower scores indicating better functioning. 0. Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
|
| Clinical T stage | T stage were staged using the 8th edition of the American Joint Committee of Cancer (AJCC) tumor-node-metastasis (TNM) staging classification for colon cancer. cT3:Tumor invades through the muscularis propria into pericolorectal tissues; cT4a:Tumor invades through the visceral peritoneum (including gross perforation of the bowel through tumor and continuous invasion of tumor through areas of inflammation to the surface of the visceral peritoneum); cT4b:Tumor directly invades or adheres to adjacent organs or structures | Count of Participants | Participants |
|
| Clinical N stage | cN0:No regional lymph node metastasis; cN1:One to three regional lymph nodes are positive (tumor in lymph nodes measuring ≥0.2 mm), or any number of tumor deposits are present and all identifiable lymph nodes are negative; cN2: Four or more regional lymph nodes are positive | Count of Participants | Participants |
|
| MMR status | pMMR:proficient mismatch repair; dMMR:deficiency in mismatch repair | Count of Participants | Participants |
|
|
| Secondary | Pathologic Complete Response (pCR) Rates | Percentage of patients with pathological complete response | Not Posted | Dec 2025 | 2 years | Participants |
| Secondary | R0 Resection Rate | R0 resection accounted for the percentage of all surgical patients=100% | Not Posted | Dec 2025 | 2 years | Participants |
| Secondary | The Rate of 2 Year Disease Free Survival (DFS) | Disease-free survival (DFS) is defined as the time from operation to recurrence of tumor or death. We will evaluate 2 year DFS is 100% | Not Posted | Dec 2025 | 2 years | Participants |
| Secondary | Overall Survival (OS) | Refers to the time of death from enrollment to any cause | Not Posted | 2 years | Participants |
| Secondary | Event Free Survival (EFS) | The period from the beginning of neoadjuvant therapy to the occurrence of any of the following events, whichever occurs first: tumor progression as assessed by RECIST 1.1; Tumor recurrence, including local recurrence or distant metastasis; Death from any cause; EFS=100% | Not Posted | Dec 2025 | 2 years | Participants |
| Secondary | Perioperative Complication Rate | The complication rate of all patients during the period around the time of a surgical operation | Not Posted | 3 months | Participants |
| Secondary | Mortality Rate | the ratio between deaths and all patients in the study during treatment | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 12 |
| 10 |
| 12 |
| 8 |
| 12 |
| decreased white blood cell count | Blood and lymphatic system disorders | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hypertension | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| ALT increased | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| RCCEP | Cardiac disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |