Study of TQB2450 in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck(R/M SCCHN)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Research Team
Eligibility Criteria
Inclusion Criteria
Histologically or cytologically confirmed head and neck squamous cell carcinoma ,primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx.
No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.
At least one measurable lesion( based on RECIST1.1).
See 7 more
Treatment Details
Interventions
- TQB2450 (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)Experimental Treatment1 Intervention
Group II: placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)Placebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Lead Sponsor
Trials
344
Recruited
43,600+
Shanchun Wang
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chief Medical Officer since 2019
MD, Peking University Health Science Center
Eric S. Y. Tse
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chief Executive Officer since 2020
MBA, Harvard Business School