Camrelizumab in Combination With Cetuximab and Chemotherapy for Relapsed/Metastatic HNSCC Patients

Phase 2

Recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: Camrelizumab+cetuximab+chemotherapy

• Registration Number: NCT05673577
• Lead Sponsor: Fudan University

Brief Summary

This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of camrelizumab in combination with cetuximab and chemotherapy as first-line for patients with relapsed/metastastic head and neck squamous cell carcinoma

Detailed Description

Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative-intent therapies have poor survival.

At present, the standard treatment is cetuximab and chemotherapy plus PD-1 inhibitor Regimen.

This study is a phase II, prospective, single arm，single-center study, which requires a total of 40 R/M HNSCC patients. Patients will receive no more than 6 cycles of albumin paclitaxel and cisplatin, repeated every 3 weeks. PD-1 inhibitor will be administered until progression every 3 weeks. Cetuximab will be administered 400 mg/m2 at first dose, following by 250 mg/m2 after first dose until progression, repeated every 3 weeks.

Study Timeline

• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-06
• Study Start: 2023-03-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab+cetuximab+chemotherapy	Camrelizumab+cetuximab+chemotherapy	Camrelizumab: 200mg vgtt q3w, 3 weeks as a cycle; Cetuximab first dose 400mg/m2, vgtt, following by 250 mg/m2 after first dose, qw, 3 weeks as a cycle; albumin paclitaxel: 125mg/m2, vgtt, d1, 8, q3w，for up to 6 cycles; cisplatin: 75mg/m2, vgtt，d1，q3w, for up to 6 cycles; Then, in maintenance therapy, Camrelizumab: 200mg vgtt q2w; Cetuximab 500mg/m2, vgtt q2w until intolerable toxicity or disease progression

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	2 years after enrollment of final patient	Objective response rate measured as number of complete and partial response divided by the number of patients included.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	up to 2 years	Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Adverse events	Since the signing of informed consent forms to 30 days after the last cycle	Hematologic and non hematologic adverse event (CTCAE 5.0）
Progression-free Survival (PFS)	up to 2 years	Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Trial Locations

Locations (1)

Fudan University; 🇨🇳 Shanghai, China