Disitamab vedotin (RC48) plus carboplatin as first-line treatment for advanced HER2-positive ovarian, fallopian tube, or primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-center interventional trial gives disitamab vedotin (RC48) combined with carboplatin to patients with stage II–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who are chemotherapy-naive after initial debulking surgery (R0 or R1). Eligible patients must have HER2 protein expression of IHC 2+ or 3+, ECOG performance status ≤2, and adequate organ function including cardiac, hepatic, renal, and hematologic parameters. The regimen replaces standard paclitaxel with RC48 in first-line therapy and monitors tumor responses and adverse events across treatment cycles. All treatment and follow-up visits are conducted at Zhejiang Cancer Hospital in Zhejiang, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;
* Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;
* HER2 expression: IHC 2+ or 3+;
* Had not received chemotherapy before enrollment;
* ECOG PS ≤ 2;
* Expected survival period ≥ 3 months;
* Adequate organ function. During the screening period, the following criteria should be met (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); When there is no liver metastasis, ALT and AST ≤ 2.5 × ULN, and when there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula;
* Non-pregnant women;
* Signed a written informed consent form before the trial.

Exclusion Criteria:

* Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);
* The subject had central nervous system diseases or brain metastases;
* Had previously experienced grade II or above peripheral neuropathy;
* Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
* Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);
* Had known allergies to the study-related drugs or their excipients or was intolerant to them;
* Was participating in other clinical trials at the same time;
* Subjects judged by the researcher to be unsuitable for this study.

Where it's running

• Zhe Jiang Cancer Hospital
  Zhejiang, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Shao
• Email: shaozy@zjcc.org.cn
• Phone: +8613486127234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.