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

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Camrelizumab; Drug: Concurrent cisplatin chemotherapy; Radiation: Intensity-modulated radiotherapy (IMRT)

• Registration Number: NCT05213884
• Lead Sponsor: Chongqing University Cancer Hospital

Brief 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.

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-01-16
• Study First Posted: 2022-01-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab plus chemoradiotherapy	Concurrent cisplatin chemotherapy	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.
Camrelizumab plus chemoradiotherapy	Intensity-modulated radiotherapy (IMRT)	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.
Camrelizumab plus chemoradiotherapy	Camrelizumab	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 Measures

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

Secondary Outcome Measures

Name	Time	Method
EFFICACY Objective response rate (ORR）	2 years	Defined as a complete response (CR) or partial response (PR) from enrolled until disease progression or death due to any cause.
EFFICACY Duration of response (DOR)	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.
SAFETY Incidence rate of adverse events (AEs)	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.
QUALITY OF LIFE Quality of life (QoL): questionnaire	2 years	QoL is evaluated with the use of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
EFFICACY Overall survival (OS)	2 years	Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.

Trial Locations

Locations (3)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Chongqing University Three Gorges Hospital; 🇨🇳 Wanzhou, Chongqing, China

The Affiliated Hospital of Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China