Clinical trial · Interventional
Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer
Evaluation of PEGylated Doxorubicin Hydrochloride Liposome Injection(Duomeisu®) Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer: A Randomized, Open, Multicenter Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, multicenter, open, controlled Post-Marketing Study. 396 patients who were histopathology or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer were enrolled in this study. The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and the stratification factors included: chemotherapy type (adjuvant chemotherapy/neoadjuvant chemotherapy), residual disease after surgery (\>1cm, \<1cm, no primary surgery), stage (Ic, II, III or IV), pathological typing, Eastern Cooperative Oncology Group performance status (0 to 1 or 2), BRCA1/2 gene mutation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Efficacy and Safety | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- study group
- description
- pegylated liposomal doxorubicin 30 mg/m2, i.v.,d1; carboplatin AUC 5,i.v.,d1; once every 21days, 3\~6 cycles for early stage patients and 6 cycles for late stage.
- interventionNames
- Drug: pegylated liposomal doxorubicin
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- paclitaxel 175 mg/m2, i.v.,d1; carboplatin AUC 5, i.v.,d1; once every 21days, 3\~6 cycles for early stage patients and 6 cycles for late stage.
- interventionNames
- Drug: paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18-75years old; * Histopathologically or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer; * According to the International Federation of Obstetrics and Gynecology (FIGO), the stage is Ic-IV; * Imaging assessment is based on the solid tumor efficacy evaluation standard (RECIST) version 1.1, lesions can be measured, or patients' CA125 assessed according to GCIG criteria; * Neoadjuvant chemotherapy can be given to patients with excessive tumor volume or a wide range of lesions, who are not expected to achieve ideal cytoreductions before surgery; * ECOG score ≤ 2; * Expected survival time ≥ 3 months; * LVEF ≥ 50%; * Bone Marrow Function: ANC:≥1.5×109/L; PLT:≥100×109/L;Hb: ≥90g/L; * Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or \<ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present; * The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating; * Signed the informed consent. Exclusion Criteria: * Patients with low-grade malignant potential ovarian tumors; * Patients who had previously received chemotherapy or pelvic and abdominal radiotherapy; * Patients planning to receive abdominal or pelvic chemotherapy; * The New York Heart Association (NYHA) graded class II heart disease patients (including grade II) previous or current; * Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin; * Uncontrolled systemic infection requiring anti-infective treatment; * Allergies to chemotherapeutic drugs or their excipients or intolerant patients; * Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03; * Researchers think it is not suitable for enrolling.
References
Publications (1)
- DERIVEDShen Y, Tu N, Kong B, Xia B, Zou Y, Yin R, Li Q, Yue Y, Kang S, Wang K, He L, Wang S, Meng Y, Qu P, Huang X, Guo R, Yan P, Pan M, Cheng W, Lou G, Wang Z. Pegylated liposomal doxorubicin plus carboplatin versus paclitaxel plus carboplatin as first-line therapy for epithelial ovarian cancer (CGCS-04): a multicenter, randomized clinical trial. Ther Adv Med Oncol. 2026 Feb 16;18:17588359261420402. doi: 10.1177/17588359261420402. eCollection 2026. PMID 41709925