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Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths. A considerable number of patients have simple local recurrence in the short term after operation suggesting that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. This project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.
Head and neck squamous cell carcinoma (HNSCC) refers to the general name of squamous cell carcinoma in head and neck organs except nasopharyngeal carcinoma. The main primary sites include oral cavity, oropharynx, hypopharynx, larynx and cervical esophagus. At present, the incidence rate of head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths, of which squamous cell carcinoma accounts for more than 95%.
In daily clinical work, due to insufficient neck cleaning, slow postoperative incision recovery, long waiting time for treatment, untimely postoperative referral and other reasons, a considerable number of patients have simple local recurrence in the short term after operation (e.g. within 6 months) and before the start of planned adjuvant radiotherapy, so that the purpose of PORT has evolved from initial adjuvant treatment to palliative treatment, It also suggests that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. Based on the current clinical and research status, for HNSCC with local regional recurrence in a short time (< 6 months) after operation, both local regional control and remote control must be considered in treatment。 Therefore, this project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+(Cisplatin or Carboplatin or Lobaplatin or Nedaplatin)+radiotherapy | Experimental | patients with short-term postoperative progression receive camrelizumab and platin-based chemotherapy concurrent with radiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200mg, iv, d1, q3w |
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| Measure | Description | Time Frame |
|---|---|---|
| 1 year Progression-free survival (1y-PFS) | Proportion of patients with disease-free survival at 3 years after randomization | up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1. | From the start of randomization to a minimum of 24 months |
| Disease Control Rate (DCR) | Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingbo Wang | Contact | +8618500369703 | wangjingbo201001@163.com | |
| Gulidanna Shayan | Contact | 18500369703 | gldanna@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingbo Wang | Chinese academy of medical science, cancer hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100020 | China |
IPD will be avaliable upon request to PI
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| Cisplatin | Drug | 80-100mg/m2, iv, q3w, 2-3 cycles in total |
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| Carboplatin | Drug | AUC 2, iv, q1w, 5-7 cycles in total |
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| Lobaplatin | Drug | 30mg/m2, iv, q3w, 2-3 cycles in total |
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| Nedaplatin | Drug | 25-30 mg/m2, iv, q1w, 5-7 cycles in total |
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| Radiotherapy | Radiation | PGTVp/PGTVnd 66-70Gy/2-2.2Gy/30-35F;PTV1 60Gy/1.8-2.0Gy/30-33F;PTV2 50Gy/1.8-20Gy/25-28F;Start 1-2 weeks after the start of immunotherapy, 1 time before the start of simultaneous chemotherapy, up to 3 times during the concurrent chemoradiotherapy |
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| From the start of randomization to a minimum of 24 months |
| Duration of Response (DoR) | DoR is defined as the time from the measurement of the first compliance with Cr or pr (whichever occurs first) to the first true recording of disease recurrence or progression. | From the start of randomization to a minimum of 48 months |
| Overall survival (OS) | OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death. | From the start of randomization to a minimum of 48 months |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. | From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 2 years |
| 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 |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D007167 | Immunotherapy |
| D002945 | Cisplatin |
| D004358 | Drug Therapy |
| D016190 | Carboplatin |
| C066228 | lobaplatin |
| C053989 | nedaplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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