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RECRUITING
NCT05213884
PHASE2

The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC

Sponsor: Chongqing University Cancer Hospital

View on ClinicalTrials.gov

Summary

This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.

Official title: A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-01-01

Completion Date

2027-01-01

Last Updated

2023-05-06

Healthy Volunteers

No

Interventions

DRUG

Camrelizumab

200 mg, intravenous infusion over 30 minutes (Q3W); 1\~3 cycles of camrelizumab before radiotherapy and camrelizumab are maintained for 16 cycles (1 year) after the end of radiotherapy.

DRUG

Concurrent cisplatin chemotherapy

cisplatin is given at a dose of 40 mg/m2 via intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy every week for 6 cycles.

RADIATION

Intensity-modulated radiotherapy (IMRT)

70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.

Locations (3)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Chongqing University Three Gorges Hospital

Wanzhou, Chongqing Municipality, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China