Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A2102 for Injection, Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection.
- Who it may be relevant to
- Registry conditions: Recurrent Cervical Cancer, Metastatic Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug SHR-A2102 for Injection
SHR-A2102 for injection. - Drug Pemetrexed Disodium for Injection
Pemetrexed Disodium for injection. - Drug Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection. - Drug Topotecan Hydrochloride for Injection
Topotecan Hydrochloride for injection. - Drug Paclitaxel for Injection (Albumin bound)
Paclitaxel for injection (Albumin bound).
Primary outcome measures
- Overall survival (OS) [Time frame: Up to 3 years.]
Secondary outcome measures (10)
- Progression free survival (PFS) [Time frame: Up to 3 years.]
- Objective Response Rate (ORR) [Time frame: Up to 3 years.]
- Duration of response (DoR) [Time frame: Up to 3 years.]
- Disease control rate (DCR) [Time frame: Up to 3 years.]
- Adverse Events (AEs) [Time frame: Up to 3 years.]
- Serious Adverse Events (AEs) [Time frame: Up to 3 years.]
- Plasma concentrations of SHR-A2102 [Time frame: Up to 3 years.]
- Plasma concentrations of SHR-A2102 metabolites [Time frame: Up to 3 years.]
- Incidence of Anti-Drug Antibody (ADA) of SHR-A2102 [Time frame: Up to 3 years.]
- Incidence of Neutralizing Antibodies (Nab) of SHR-A2102 [Time frame: Up to 3 years.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07418749 · SHR-A2102-310