Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intrap… (NCT07407452) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer
China50 participantsStarted 2026-02-01
Plain-language summary
This study is a prospective, open-label, multicenter Phase II clinical trial, planning to enroll 50 patients with advanced ovarian cancer. Enrolled participants will be assigned to 2 cohorts based on ECOG performance status and genetic mutation status:
Cohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + paclitaxel (175 mg/m², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)/cisplatin (75 mg/m², Q3W, D1). Planned enrollment: 30 patients.
Cohort 2: ECOG PS 2, BRCA1/2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg/m², Q3W, D1). Planned enrollment: 20 patients.
Neoadjuvant therapy will be administered for 3 cycles, followed by patient status assessment. Patients with CR/PR/SD will be allowed to undergo surgery, while PD patients will have subsequent treatment strategies determined by the investigator.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion Criteria:
* Participants voluntarily join this study, sign the informed consent form, and strictly comply with the protocol requirements;
* Female patients aged between 18 and 75 years;
* Patients who have undergone open surgery, laparoscopic surgery, or core needle aspiration biopsy, and have been histopathologically confirmed as having epithelial ovarian cancer (high-grade serous adenocarcinoma, endometrioid adenocarcinoma), peritoneal cancer, or fallopian tube cancer, FIGO 2018 Stage III-IV;
* Meet the indications for neoadjuvant chemotherapy in ovarian cancer: ①Preoperative assessment by gynecologic oncologists (with multidisciplinary consultation when necessary) indicates low likelihood of achieving R0 resection with primary debulking surgery; ② Physical condition unable to tolerate PDS, unsuitable for immediate surgery (e.g., high perioperative risk, advanced age, medical comorbidities, etc.); ③ No prior systemic anti-tumor treatment for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy); Note: Lymph node dissection or biopsy performed for clinical staging purposes after obtaining histopathology via needle biopsy, laparoscopic exploration, or other methods is permitted;
* Accept BRCA1/2 genetic mutation or HRD testing;
* Presence of at least one measurable lesion according to RECIST 1.1 criteria;
* Expected survival time ≥12 weeks;
* ECOG score 0-1 (for Cohort 1), ECOG score 2 (for Cohort 2)…
What they're measuring
1
AEs
Timeframe: From enrollment to the end of treatment at 9 weeks