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

Sponsor

Chongqing University Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05213884

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma	Drug: Camrelizumab Drug: Concurrent cisplatin chemotherapy Radiation: Intensity-modulated radiotherapy (IMRT)	Phase 2

Detailed Description

All participants 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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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 (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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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