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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).
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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 profile image

Eric S. Y. Tse

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Chief Executive Officer since 2020

MBA, Harvard Business School