An Open-label, Randomized, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical cancer.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• Participate in the study voluntarily, sign the informed consent form.
• Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy.
• Provide primary or metastatic tumor samples.
• At least one measurable lesion (RECIST version 1.1).
• ECOG 0\
• With adequate organ functions.
• Expected overall survival is ≥12 weeks.
Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Zhifei Lin
zhifei.lin.zl3@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2026-03-30
Estimated Completion Date: 2028-12
Participants
Target number of participants: 398
Treatments
Experimental: SHR-A2102 Group
Participants receive SHR-A2102 for injection.
Active_comparator: The investigator's choice of chemotherapy Group
Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound).
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.