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

Sponsor
Sun Yat-sen University
Study ID
NCT04826679
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Mar 2021
Primary completion
Apr 1, 2023
Completion
Apr 1, 2026

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

ORR [ Time Frame: 9 weeks ]

Central Contacts

Related Studies