NCT06170697

Advanced First-line Treatment of Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma

A Single-arm，Single Center，Prospective，Phase II Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy for Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	200mg, iv, d1, q3w
DRUG	Cisplatin	80-100mg/m2, iv, q3w, 2-3 cycles in total
DRUG	Carboplatin	AUC 2, iv, q1w, 5-7 cycles in total
DRUG	Lobaplatin	30mg/m2, iv, q3w, 2-3 cycles in total
DRUG	Nedaplatin	25-30 mg/m2, iv, q1w, 5-7 cycles in total
RADIATION	Radiotherapy	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

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2023-12-14
• Last updated: 2023-12-20

Locations

1 site across 1 country: China