Camrelizumab Combined With Apatinib Mesylate for Head and Neck Squamous Cell Carcinoma
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study ID
- NCT04440917
- Phase
- PHASE2
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Camrelizumab — DRUG200mg, iv, on day 1, 15, 29, 43
- Apatinib Mesylate — DRUG250 mg po, qd, 28 days as a cycle, 2 cycles in total
Study Details
This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.
Key Dates
- Start date
- Jun 3, 2020
- Status verified
- Jun 2020
- Primary completion
- Jun 30, 2022
- Completion
- Dec 31, 2023
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Study groupInductive therapy with Camrelizumab and Apatinib
Primary Outcome Measure
Objective Response Rate (CR+PR) [ Time Frame: 9 weeks ]
Central Contacts
- Guopei Zhu, M.D.021-23271699
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