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

NCT04826679 | Recruiting Phase 2

• 1 other identifier: OBU-GD1-BC-HNC-II-001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  9 weeks

Secondary Outcomes (6)

• pCR

  9 weeks

• MPR

  9 weeks

• DCR

  9 weeks

• PFS

  2 years

• OS

  5 years

Study Arms (1)

Experimental

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.

Drug: Camrelizumab, nab-paclitaxel, cisplatin

Interventions

Camrelizumab, nab-paclitaxel, cisplatin 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.

Also known as: Camrelizumab and chemotherapy

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2N2-3M0、T3-4N0-3M0（III-IV）（AJCC 8.0）
• Greater than or equal to 18 and less than 65 years of age at time of study entry.
• ECOG performance status of 0 or 1.
• Resectable or potentially resectable lesion, without distance metastasis;
• Measurable disease as per RECIST 1.1.
• Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
• 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；
• 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.

You may not qualify if:

• Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
• Active, known or suspected autoimmune disease, including dementia and epilepsy.
• Has had another known invasive malignancy or unresectable cancer.
• Coagulation dysfunction: (PT \> 16S, APTT \> 53s, TT \> 21s, FIB \< 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
• Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
• Laboratory abnormality within 7 days before enrollment.
• 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.
• Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
• Has a known history of Human Immunodeficiency Virus (HIV).
• 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.
• have received anti-tumor herbs within 4 weeks before randomization.
• Pregnant or nursing women.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; Cisplatin; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• xuekui Liu

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xuekui Liu

CONTACT

13609713406; Liuxk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2026
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)