NCT07418749 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
| NCT ID | NCT07418749 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Recurrent Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 398 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 398 participants in total. It began in 2026-03-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Participate in the study voluntarily, sign the informed consent form. 2. 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. 3. Provide primary or metastatic tumor samples. 4. At least one measurable lesion (RECIST version 1.1). 5. ECOG 0\~ 1. 6. With adequate organ functions. 7. Expected overall survival is ≥12 weeks. Exclusion Criteria: 1. With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis. 2. With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites. 3. With a history of or concurrent other malignant tumor(s). 4. Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization. 5. With known or suspected interstitial lung disease. 6. With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization. 7. With poorly controlled cardiac clinical symptoms or diseases. 8. Experienced arterial/venous thromboembolic events within 3 months prior to randomization. 9. With severe infections occurring within 1 month prior to randomization. 10. 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). 11. 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. 12. 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. 13. Have received systemic anti-tumor therapy within 28 days prior to randomization. 14. 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. 15. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07418749 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Recurrent Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07418749 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 398 participants.
Is NCT07418749 currently recruiting?
Yes, NCT07418749 is actively recruiting participants. Contact the research team at zhifei.lin.zl3@hengrui.com for enrollment information.
Where is the NCT07418749 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07418749 clinical trial?
NCT07418749 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 398 participants.
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