SHR-A2102 compared with chemotherapy for cervical cancer that returned or spread after earlier treatment
Compares SHR-A2102 with chemotherapy in adults whose cervical cancer progressed after earlier treatments.
Plain-language title generated from the registry record
Registry title: A 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
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Trial code
- NCT07418749
- Record updated
- 6 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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~ 1; With adequate organ functions; Expected overall survival is ≥12 weeks.
Exclusion: With a history of or concurrent other malignant tumor(s); Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization; With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization; Experienced arterial/venous thromboembolic events within 3 months prior to randomization; With severe infections occurring within 1 month prior to randomization; With active tuberculosis infection within 1 year prior to randomization, or a history of active tuberculosis infection more than 1 year ago without proper treatment; Have received systemic anti-tumor therapy within 28 days prior to randomization; With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis; With known or suspected interstitial lung disease; With poorly controlled cardiac clinical symptoms or diseases; With active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] test and hepatitis B virus [HBV] DNA ≥500 IU/mL at screening) or active hepatitis C (defined as positive hepatitis C virus antibody [HCV-Ab] test and detectable hepatitis C virus [HCV] RNA at screening); With a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; With uncontrolled psychiatric disorders, or known history of alcoholism, drug abuse, or substance dependence, incarceration, or other conditions that may affect the completion of study procedures; Any other condition that, in the judgment of the investigator, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the participant unsuitable for the study; With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.