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

April 21, 2026 updated by: Ying Wang, Chongqing University Cancer Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants from 3 hospitals will receive 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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing University Cancer Hospital
      • Wanzhou, Chongqing Municipality, China, 404100
        • Chongqing University Three Gorges Hospital
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • The Affiliated Hospital of Southwest Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females ≥18 years of age.
  2. ECOG Performance Status 0 or 1.
  3. Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
  4. Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
  5. Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
  6. With measurable target lesions by CT or MRI.
  7. Adequate bone marrow function.
  8. Adequate renal and liver function.
  9. Pregnancy test (for patients of childbearing potential) negative at screening.
  10. Signed Written Informed Consent.

Exclusion Criteria:

  1. Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
  2. Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
  3. Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
  4. Pregnancy or breast feeding.
  5. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
  6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
  7. Has received a live vaccine within 4 weeks of planned start of study therapy.
  8. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Anti-PD-1 antibody
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFFICACY Progress-free survival (PFS)
Time Frame: 2 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFFICACY Overall survival (OS)
Time Frame: 2 years
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
2 years
EFFICACY Objective response rate (ORR）
Time Frame: 2 years
Defined as a complete response (CR) or partial response (PR) from enrolled until disease progression or death due to any cause.
2 years
EFFICACY Duration of response (DOR)
Time Frame: 2 years
Defined as the time from the first assessment of CR or PR to the first assessment of disease progression or death due to any cause.
2 years
SAFETY Incidence rate of adverse events (AEs)
Time Frame: 2 years
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs, according to the Common Terminology Criteria for Adverse Events, version 5.0.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing University Cancer Hospital

Investigators

  • Principal Investigator: Ying Wang, Ph.D, M.D., Chongqing University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

February 8, 2026

Study Completion (Actual)

February 8, 2026

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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