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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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In this single-arm study, pathologically confirmed advanced head and neck squamous cell carcinoma will be enrolled to investigate the efficacy and safety of Camrelizumab in combination With albumin paclitaxel and cisplatin.
First, the patient received neoadjuvant therapy once every three weeks for a total of three cycles(Camrelizumab in combination With albumin paclitaxel and cisplatin).After the neoadjuvant treatment, the patient undergoes surgery and postoperative radiotherapy.According to the surgical margin and postoperative pathological conditions, combined with cisplatin concurrent chemotherapy as appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab,albumin paclitaxel and cisplatin. | Experimental | Participants will be given intravenous administration of Camrelizumab (200mg),Albumin Paclitaxel(260mg/m²) and Cisplatin(80mg/m²),After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy. The duration of treatment will till death, or unacceptable toxicity show up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor | Drug | Intravenous administration of SHR1210 (200mg/3weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rate(CRR) | the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer | immediately after the surgery |
| Pathological remission rate(PRR) | the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer | immediately after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year survival rate, 2-year progression-free survival rate, 2-year recurrence-free survival rate, 2-year survival rate without distant metastasis | 1. the long-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
Patients who pathologically confirmed non-squamous cell carcinoma
Patients who has recurrence or distant metastasis
Local lesions have been surgically removed
Patients who have received systemic anti-cancer therapy, including hormone therapy
Patients who have received treatment targeting PD-1 or PD-L1
Patients with active autoimmune disease or a history of autoimmune disease but may relapse(Patients with the following diseases are not excluded and can be further filtered)
Any active malignant tumors within 2 years before treatment, except for the specific cancers being studied in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical in situ Cancer or breast cancer)
Any disease requiring systemic treatment with corticosteroids (referring to treatment with a dose higher than 10 mg/day of prednisone or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days before treatment.
However, patients who have currently or previously used any of the following steroid regimens can be selected:
Uncontrolled diabetes within 14 days before treatment or laboratory abnormalities with potassium, sodium and corrected calcium levels> 1 after standard drug treatment or hypoalbuminemia grade ≥ 3
History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, etc.
Severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibiotics, antibacterial or antiviral treatment occurred within 14 days before the first administration of the study drug
The patient is known to have been infected with HIV
Untreated patients with chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA ≥ 500 IU/mL or active hepatitis C virus carriers (HCV) should be excluded.
Patients can be selected who is Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA <500 IU/mL) and cured hepatitis C patients.
Any surgery requiring general anesthesia has been performed within 28 days before treatment
Have had allogeneic stem cell transplantation or organ transplantation
Have any of the following cardiovascular risk factors:
Have a history of severe hypersensitivity to other monoclonal antibodies
Patients with treatment toxicity (caused by previous anti-cancer treatments) have not returned to baseline or stabilized, unless it is an AE that is not considered a possible safety risk (such as hair loss, neuropathy, or specific laboratory abnormalities)
History of allergic reactions to cisplatin or other platinum-containing compounds
Peripheral nerve disease ≥ Grade 2 defined by NCI CTCAE v5.0 standard Have gotten a live vaccine within 4 weeks before treatment(Seasonal flu vaccines are usually inactivated vaccines and are allowed to be used; The vaccine used in the nasal cavity is a live vaccine and is not allowed to be used)
Abuse or dependence on alcohol or drugs and Basic medical conditions (including laboratory abnormalities) that are not conducive to the administration of the study drug , affect the interpretation of drug toxicity or AEs, lead to insufficient compliance with the study execution and possible damage
The patient participates in another therapeutic clinical study at the same time
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaqian Han | Contact | 18673176667 | hanyaqiancs@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaqian Han | Hunan Cancer Hospital | Principal Investigator |
| Wenxiao Huang | Hunan Cancer Hospital | Principal Investigator |
| Hui Wang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan cancer Hospital | Recruiting | Changsha | Hunan | China |
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
please contact the principal investigator of this study or correspondence author of published work.
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Patients fulfilling Eligibility Criteria will be included in our study.Participants will be given intravenous administration of Camrelizumab (200mg),Albumin Paclitaxel(260mg/m²) and Cisplatin(80mg/m²),After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy.Treatments will be administrated until death, or unacceptable toxicity.
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| Albumin Paclitaxel | Drug | Albumin Paclitaxel(260mg/m²),every 3 weeks |
|
| Cisplatin | Drug | Cisplatin(80mg/m²), every 3 weeks |
|
| Adverse event rate |
The safety of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer |
| 2 year |
| Hunan Cancer Hospital |
| Principal Investigator |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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