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Recruiting NCT06394492

SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Phase III Interventional Ovarian 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-A1921, Doxorubicin, Paclitaxel, Topotecan.
Who it may be relevant to
Registry conditions: Ovarian 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

A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Overview

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Interventions

  • Drug SHR-A1921
    SHR-A1921 dose 1
  • Drug Doxorubicin
    Doxorubicin dose 2
  • Drug Paclitaxel
    Paclitaxel dose 3
  • Drug Topotecan
    Topotecan dose 4

Primary outcome measures

  • Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
Secondary outcome measures (7)
  • Overall Survival (OS) [Time frame: Screening up to study completion, an average of 1 year]
  • Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
  • Duration of Response (DoR), assessed by site investigator as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
  • Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1 [Time frame: Screening up to study completion, an average of 1 year]
  • Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria [Time frame: Screening up to study completion, an average of 1 year]
  • CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria [Time frame: Screening up to study completion, an average of 1 year]
  • Adverse Events [Time frame: Screening up to study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Voluntary participation and written informed consent.
  • 18 years and older, female.
  • Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Patients must have platinum-resistant disease
  • Be able to provide fresh or archived tumour tissue.
  • At least one measurable lesion according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1.
  • With a life expectancy ≥ 12 weeks.
  • Adequate bone marrow reserve and organ function.
  • Contraception is required during the trial.

Exclusion criteria

  • Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
  • Previous or co-existing malignancies.
  • Current or History of ILD.
  • Clinical symptoms or diseases of the heart that are not well controlled.
  • Arterial/venous thrombosis events occurred before the first dose.
  • Grade ≥2 bleeding events of CTCAE occurred before the first dose.
  • Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
  • Patients with intestinal obstruction or parenteral nutrition before the first dose.
  • Serious infection before the first dose.
  • Active hepatitis B or active hepatitis C.
  • Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
  • Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
  • Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
  • History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
  • Other inappropriate situation considered by the investigator.

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 · 2 centers
  • National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Unio — Beijing
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT06394492 · SHR-A1921-303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗