SHR-A2102 versus investigator's choice chemotherapy for recurrent or metastatic cervical cancer after platinum and PD-(L)1 therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized Phase 3 trial comparing SHR-A2102 to investigator-selected chemotherapy (pemetrexed, gemcitabine, topotecan, or albumin‑bound paclitaxel) in patients with recurrent or metastatic cervical squamous, adenocarcinoma, or adenosquamous carcinoma after prior platinum and PD-(L)1 inhibitor therapy. Eligible patients must have measurable disease by RECIST 1.1, ECOG performance status 0–1, adequate organ function, and provide tumor tissue samples. Participants are randomized to receive the study drug or physician's choice chemotherapy with regular imaging and clinical assessments to measure tumor response, safety, and survival outcomes. Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified discontinuation criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Zhifei Lin
• Email: zhifei.lin.zl3@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.