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Compares treatment options for Recurrent Cervical Cancer
Official 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
ClinicalTrials.gov ID: NCT07418749
What this study is testing
What is SHR-A2102 for Injection?
SHR-A2102 for Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- Provide primary or metastatic tumor samples.
- At least one measurable lesion (RECIST version 1.1).
- ECOG 0\~ 1.
You likely can't join 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.
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.