New drug duo aims to outperform chemo in rare ovarian cancer
NCT ID NCT07002346
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether a new immunotherapy drug (QL1706) combined with bevacizumab can slow cancer growth better than standard chemotherapy in women with advanced ovarian clear cell carcinoma. About 226 participants will be randomly assigned to receive either the experimental combo or chemo (with or without bevacizumab). The study tracks how long the cancer stays under control and monitors side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QL1706 (a drug that targets two immune checkpoints, PD-1 and CTLA-4) plus bevacizumab
- What this could lead to
- If it works, this could offer a new first-line treatment option that delays cancer progression better than standard chemotherapy for women with advanced ovarian clear cell carcinoma.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. The experimental combination may not improve outcomes and could cause side effects like immune-related inflammation or bleeding risks from bevacizumab.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 226 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary participation in the study and signed informed consent form. * Age ≥ 18 years and \< 75 years, female. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected survival ≥ 3 months. * Histologically or cytologically newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. * Patients are planned to undergo primary debulking surgery (PDS), regardless of whether satisfactory debulking is achieved, and have complete surgical records and residual disease assessment results (R0 vs R1/R2). * No prior first-line postoperative systemic antitumor therapy for the current ovarian clear cell carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc. * Adequate organ function confirmed by the following requirements: Hematological (no use of any blood components or cell growth factors within 7 days prior to initiation of study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (1,500/mm\^3). ii. Platelet count ≥ 100 × 10\^9/L (100,000/mm\^3). iii. Hemoglobin ≥ 90 g/L. Renal: i. Calculated creatinine clearance (CrCl) ≥ 50 mL/min. CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = \[(140 - age) × weight (kg) × F\] / \[SCr (mg/dL) × 72\], where F = 0.85 for females and SCr = serum creatinine. ii. Urine protein \< 2+ or 24-hour quantitative urine protein \< 1.0 g. Hepatic: i. Total serum bilirubin (TBil) ≤ 1.5 × ULN. ii. AST and ALT ≤ 2.5 × ULN. Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. \- For women of childbearing potential, a negative serum or urine pregnancy test within one week prior to enrollment, and effective contraceptive measures must be used after enrollment, for example, use of physical barrier contraception (condoms) or complete abstinence. Oral, injectable, or implantable hormonal contraceptives are not permitted. Or, women of non-childbearing potential, defined as: i. Naturally postmenopausal for at least 1 year. ii. Surgically sterile, including bilateral oophorectomy, bilateral salpingectomy, or hysterectomy. iii. Serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels within the postmenopausal range for the study center's laboratory. * Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements. * Patient is willing to cooperate in completing quality of life questionnaires during the trial treatment and follow-up period, and agrees that these questionnaire results can be used for clinical research. Exclusion Criteria: * Histologically confirmed ovarian cancer of other epithelial origin or non-epithelial origin, other than ovarian clear cell carcinoma; ovarian tumors of low malignant potential, such as borderline tumors. * Prior systemic preoperative antitumor therapy for the current ovarian clear cell carcinoma, including but not limited to neoadjuvant chemotherapy (NACT) or other types of neoadjuvant therapy, or planned neoadjuvant therapy followed by interval debulking surgery (IDS) during screening. * Prior treatment with immune checkpoint inhibitors, such as PD-1/PD-L1 antibodies, or drugs targeting other T-cell receptors, such as CTLA-4, as well as immune checkpoint agonist antibodies, such as anti-ICOS, CD40, CD137, GITR, or OX40 antibodies, and immune cell therapy. * Systemic use of corticosteroids or other immunosuppressive drugs, such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or TNFα inhibitors, within 2 weeks before the first dose. Note: Inhaled or topical steroids, steroids as premedication for hypersensitivity reactions, such as CT scan contrast agent premedication or cytotoxic chemotherapy premedication, or adrenal replacement steroids, daily ≤10 mg prednisone or equivalent, are permitted in the absence of active autoimmune disease. * Prior, within 5 years, or concurrent malignancies, with the exception of cured local tumors, such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc., and breast cancer with no recurrence \>3 years after radical surgery. * Patients with contraindications to bevacizumab, including but not limited to prior gastrointestinal perforation, surgery within 28 days before medication or incompletely healed wounds, severe bleeding or recent hemoptysis, or other situations where the investigator deems bevacizumab unsuitable. * Receipt of live vaccine within 30 days before the first dose of study treatment, persisting until 90 days after the last dose of study treatment. Note: Live vaccines include but are not limited to measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza virus vaccines not containing live virus, inactivated COVID-19 vaccines, etc., are permitted. * Active autoimmune disease requiring systemic treatment, such as use of disease-modifying drugs, corticosteroids, or immunosuppressants, within 2 years before the first dose. Replacement therapies, such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, are not considered systemic treatment. Note: Patients with cataracts, Graves' disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded. * Systemic infection requiring systemic antibiotic treatment or other severe infections within 2 weeks before randomization, or unexplained fever \>38.0°C during the screening period or before enrollment, and inability to discontinue aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for more than 5 days. * Severe illness or concomitant non-tumor diseases, such as neurological disorders, psychiatric disorders, infectious diseases, or laboratory abnormalities, that may increase the risk of participating in the study or taking study drugs, and which the investigator deems would make the patient unsuitable for the study. * Pregnant or lactating women. * Clinically significant cardiovascular diseases, including but not limited to: 1. Myocardial infarction or unstable angina within 6 months before the first dose. 2. Stroke or transient ischemic attack within 6 months before the first dose. 3. Hypertension not controlled by optimal antihypertensive therapy, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg. 4. Poorly controlled arrhythmias. Patients who have stabilized before the first dose and have been stable for ≥14 days may be enrolled. 5. Congestive heart failure, New York Heart Association (NYHA) functional class II-IV. 6. Myocarditis. * Expectation of needing any other form of anti-tumor therapy during the study period. * Receipt of traditional Chinese medicines with anti-tumor indications or immunomodulatory drugs, including but not limited to thymosin, interferon, interleukin-2, etc., within 2 weeks before the first dose. * HIV-positive patients. * Known history of anti-tuberculosis treatment within one year before the first administration of study treatment. * Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) ≥2000 IU/mL or 10\^4 copies/mL; HCV antibody positive and HCV RNA positive. * Pre-existing peripheral neuropathy of grade ≥2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. * Current or recent, within 10 days before the first dose of study drug, continuous use of full-dose oral or parenteral anticoagulants or thrombolytic agents for 10 days. Note: Prophylactic use of low-dose anticoagulants is permitted, including low-dose warfarin (≤1 mg/day), low-dose heparin (≤12,000 U/day), or low-dose aspirin (≤100 mg/day), provided the prothrombin time international normalized ratio (INR) is ≤1.5. * Hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis, or imaging showing tumor invasion/infiltration of major blood vessels, or investigator or radiologist assessment of bleeding tendency. * Known history of severe allergy to macromolecular protein preparations, or to any component of QL1706 or other investigational drugs, or severe allergic history to chemotherapeutic drugs such as carboplatin, paclitaxel, nab-paclitaxel, or their premedications. * Currently participating in interventional clinical research treatment, or receiving any other investigational drug or research device treatment within 4 weeks before the first dose. Patients who failed screening for other clinical trials may be included in this study. * Patients deemed unsuitable for participation in this study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital
RECRUITINGWuhan, Hubei, 430000, China
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