Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Camrelizumab, nab-paclitaxel, cisplatin

• Registration Number: NCT04826679
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This study is a single arm phase II trial including 53 patients with T2N2-3M0、T3-4N0-3M0（III-IV） head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive neo-adjvuant Camrelizumab combined with cisplatin and Nab-paclitaxel.

This proposed study will evaluate the efficacy and safety of preoperative administration of Camrelizumab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.

Detailed Description

In this study, eligible subject will be enrolled into study arm to accept study treatment. Objective response rate will be the primary outcome measures.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study Start: 2021-04-01
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Primary Completion: 2023-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

1. Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
2. Active, known or suspected autoimmune disease, including dementia and epilepsy.
3. Has had another known invasive malignancy or unresectable cancer.
4. Coagulation dysfunction: (PT > 16S, APTT > 53s, TT > 21s, FIB < 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
5. Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
6. Laboratory abnormality within 7 days before enrollment.
7. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
8. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
9. Has a known history of Human Immunodeficiency Virus (HIV).
10. Has a known history of Hepatitis B (defined as HBV DNA ≥1000 cps/mL is detected) or known active Hepatitis C virus (defined as: HCV antibody positive) infection.
11. have received anti-tumor herbs within 4 weeks before randomization.
12. Pregnant or nursing women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Camrelizumab, nab-paclitaxel, cisplatin	Camrelizumab + Cisplatin + Nab-paclitaxel Camrelizumab (IV), dose= 200mg , day=1 , cycle length: 21 days. Cisplatin (IV), dose=60mg/m2, day= 1, cycle length: 21 days. Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.

Primary Outcome Measures

Name	Time	Method
ORR	9 weeks	overall response rate

Secondary Outcome Measures

Name	Time	Method
DCR	9 weeks	Disease Control Rate
PFS	2 years	Progression-free survival
OS	5 years	overall survival
Adverse events graded by CTCAE v5.0	90 days after the first dose of study treatment	Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).
pCR	9 weeks	Pathological Complete Response
MPR	9 weeks	Major Pathological Response

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China