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

Sponsor
Chongqing University Cancer Hospital
Study ID
NCT05213884
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    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.
  • Concurrent cisplatin chemotherapy — DRUG
    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.
  • Intensity-modulated radiotherapy (IMRT) — RADIATION
    70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Apr 2026
Primary completion
Feb 8, 2026
Completion
Feb 8, 2026

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab plus chemoradiotherapy
    Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4\~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.

Primary Outcome Measure

EFFICACY Progress-free survival (PFS) [ Time Frame: 2 years ]

Related Studies