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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SHR-A2102 for Injection
  • Pemetrexed Disodium for Injection
  • Gemcitabine Hydrochloride for Injection
  • Topotecan Hydrochloride for Injection
  • Paclitaxel for Injection (Albumin bound)

Treatment groups

398 Participants
are divided into 2 treatment groups