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
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
1 other identifier
interventional
398
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 18, 2026
February 1, 2026
1.8 years
February 11, 2026
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
Up to 3 years.
Secondary Outcomes (10)
Progression free survival (PFS)
Up to 3 years.
Objective Response Rate (ORR)
Up to 3 years.
Duration of response (DoR)
Up to 3 years.
Disease control rate (DCR)
Up to 3 years.
Adverse Events (AEs)
Up to 3 years.
- +5 more secondary outcomes
Study Arms (2)
SHR-A2102 Group
EXPERIMENTALParticipants receive SHR-A2102 for injection.
The investigator's choice of chemotherapy Group
ACTIVE COMPARATORParticipants 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).
Interventions
Pemetrexed Disodium for injection.
Gemcitabine Hydrochloride for injection.
Topotecan Hydrochloride for injection.
Paclitaxel for injection (Albumin bound).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
- With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
- 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 known or suspected interstitial lung disease.
- With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization.
- With poorly controlled cardiac clinical symptoms or diseases.
- Experienced arterial/venous thromboembolic events within 3 months prior to randomization.
- With severe infections occurring within 1 month prior to randomization.
- 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 active tuberculosis infection within 1 year prior to randomization, or a history of active tuberculosis infection more than 1 year ago without proper treatment.
- 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.
- Have received systemic anti-tumor therapy within 28 days prior to randomization.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2026
First Posted
February 18, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02