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

NCT ID: NCT04826679

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2026-04-01

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

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.

Group Type: EXPERIMENTAL

Camrelizumab, nab-paclitaxel, cisplatin

Intervention Type: DRUG

Patients receive Camrelizumab IV on day 1, nab-paclitaxel IV on day 1 and cisplatin IV on day 1.

Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Interventions

Camrelizumab, nab-paclitaxel, cisplatin

Patients receive Camrelizumab IV on day 1, nab-paclitaxel IV on day 1 and cisplatin IV on day 1.

Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Camrelizumab and chemotherapy

Eligibility Criteria

Inclusion Criteria

1. Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2N2-3M0、T3-4N0-3M0（III-IV）（AJCC 8.0）

2. Greater than or equal to 18 and less than 65 years of age at time of study entry.

3. ECOG performance status of 0 or 1.

4. Resectable or potentially resectable lesion, without distance metastasis;

5. Measurable disease as per RECIST 1.1.

6. Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:

7. Adequate hepatic、cardiac、brain and renal function as demonstrated by 1) Hematology: WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL； 2) Renal: Serum creatinine < 1.5x ULN or CrCl > 60mL/min (if using the Cockcroft-Gault formula below): 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3 x ULN)；AST/ALT ≤ 3 x ULN and ALP≤3 x ULN；ALB≥3g / dL；

8. Ability to understand and willingness to sign an IRB approved written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xuekui Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xuekui Liu

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

xuekui Liu

Role: CONTACT

Liuxk@sysucc.org.cn

13609713406

Facility Contacts

xuekui Liu

Role: primary

Liuxk@sysucc.org.cn

13609713406

Other Identifiers

OBU-GD1-BC-HNC-II-001

Identifier Type: -

Identifier Source: org_study_id