Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment

Plain-language summary

This study evaluates the efficacy and safety of Disitamab Vedotin (RC48) combined with carboplatin as a first-line treatment in patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. It is open to patients with stage II-IV disease and HER2 expression (IHC 2+ or 3+) who have had surgery and have not received prior chemotherapy. It is being carried out in Phase 2 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Zhejiang Cancer Hospital

Intervention

RC48 + Carboplatin

Start date

1/4/2025

Estimated completion

1/31/2028

Countries

China

Related genes

Locations

• Zhejiang, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.