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Iparomlimab and Tovorilimab (QL1706) Combined With Bevacizumab and Chemotherapy as Neoadjuvant Therapy for Advanced Ovarian Cancer

17 juni 2026 uppdaterad av: Jin LI, Fudan University

Iparomlimab and Tovorilimab (QL1706) Combined With Bevacizumab and Chemotherapy as Neoadjuvant Therapy for Advanced Ovarian Cancer: A Prospective, Single-Arm, Phase II Study

This is a single-center, single-arm clinical study to evaluate the efficacy and safety of iparomlimab and tovorilimab (QL1706) combined with paclitaxel, carboplatin, and bevacizumab as neoadjuvant therapy for advanced ovarian cancer.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

36

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

      • Shanghai, Kina
        • Fudan University Cancer Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Female, aged 18-75 years.
  • Histologically confirmed high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal adenocarcinoma.
  • FIGO stage III-IV unresectable ovarian cancer.
  • Life expectancy ≥16 weeks.
  • No prior anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Adequate organ function, with laboratory test results meeting the following requirements:Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (or ≤5×ULN in patients with liver metastases); Serum creatinine clearance (CrCl) >50 mL/min (calculated using the Cockcroft-Gault formula); Coagulation function: international normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN.
  • The subject agrees to use effective contraceptive measures from the signing of the informed consent form until 120 days after the last dose of the study drug. Female subjects of childbearing potential (15-49 years) must have a negative urine pregnancy test within 7 days before the start of treatment and must not be lactating. A female patient is considered to be of childbearing potential if she has menstruated, has not reached a postmenopausal state (defined as ≥12 consecutive months of amenorrhea for reasons other than menopause), and has not undergone sterilization surgery (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
  • No contraindications for surgery.
  • The subject voluntarily participates in this study, signs the informed consent form, is compliant with the protocol, and cooperates with follow-up.

Exclusion Criteria:

  • Non-epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (e.g., germ cell tumors), as well as ovarian tumors of low malignant potential (e.g., borderline ovarian tumors).
  • Prior immunotherapy, including immune checkpoint inhibitory antibodies (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (e.g., anti-ICOS, anti-CD40, anti-CD137, anti-GITR, anti-OX40 antibodies, etc.), and immune cell therapy.
  • Known hypersensitivity to large molecule protein preparations. Contraindications or allergy to any component of iparomlimab and tovorilimab (QL1706), paclitaxel, or carboplatin.
  • Major surgery (excluding diagnostic laparoscopy; local surgical treatment of isolated lesions is acceptable) within 28 days before the first dose.
  • History of allogeneic tissue/solid organ transplantation.
  • Presence of a condition requiring systemic corticosteroids (>10 mg prednisone equivalent per day) or other immunosuppressive agents (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) within 2 weeks before the first dose. Topical corticosteroids, nasal sprays, and inhaled steroids are permitted. Systemic corticosteroids for the prevention of contrast media allergy are allowed.
  • Active or potentially recurrent autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable hormone replacement therapy; type I diabetes mellitus requiring only stable insulin replacement therapy.
  • Other active malignancies within the past 5 years, except for locally curable cancers that have been cured (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast), and breast cancer that has not recurred for >3 years after radical surgery.
  • History of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
  • Symptomatic, untreated, or clinically unstable brain metastases or leptomeningeal metastases.
  • Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or diabetes that remains poorly controlled despite standard treatment; uncontrolled or symptomatic arrhythmia.
  • Thromboembolic events (e.g., cerebrovascular accident, including transient ischemic attack, cerebral hemorrhage, cerebral infarction, or pulmonary embolism) within 6 months before the start of study treatment.
  • Myocardial infarction, severe/unstable angina pectoris, or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV) within the past 12 months.
  • HIV-positive patients; HBsAg-positive with HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL; HCV antibody-positive with detectable HCV RNA.
  • Participation in another clinical trial within the previous 60 days or during the study treatment period.
  • Any other condition that, in the investigator's judgment, may interfere with the conduct of the study or the interpretation of the results. Other circumstances deemed by the investigator to make the patient unsuitable for enrollment.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Iparomlimab and Tuvoraleimab injection+Bevacizumab+Paclitaxel + Carboplatin

Paclitaxel: 135~175 mg/m², IV, on day 1, every 3 weeks (q3w).

Carboplatin: AUC 5, IV, on day 1, every 3 weeks (q3w).

Iparomlimab and Tuvonralimab (QL1706): 5 mg/kg, IV infusion over at least 30 minutes on day 1, repeated every 3 weeks.

Bevacizumab: 7.5mg/kg, IV infusion over 30-90 minutes on day 1, every 3 weeks (q3w).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
R0 resection rate
Tidsram: up to 2 years
Defined as the percentage of subjects who achieve complete resection (R0) after receiving neoadjuvant therapy.
up to 2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total överlevnad (OS)
Tidsram: upp till 2 år
Definieras som tiden från behandlingsstart till döden från vilken orsak som helst.
upp till 2 år
Antal deltagare med behandlingsrelaterade biverkningar enligt bedömning med CTCAE v5.0
Tidsram: upp till 2 år
Antal deltagare med behandlingsrelaterade biverkningar som bedömts med CTCAE v5.0
upp till 2 år
Objektiv responsfrekvens (ORR)
Tidsram: upp till 2 år
Definieras som procentandelen av försökspersoner som uppnår komplett respons (CR) eller partiell respons (PR).
upp till 2 år
pathological complete response (pCR)
Tidsram: up to 2 years
Histological examination of the entire surgically resected specimen after neoadjuvant therapy confirms the absence of viable tumor cells on all slides and negative lymph node metastasis.
up to 2 years
Progression-Free Survival (PFS)
Tidsram: up to 2 years
Defined as the time from enrollment to the date of first documented tumor progression (as assessed RECIST v1.1 criteria, regardless of whether treatment is continued) or death from any cause, whichever occurs first.
up to 2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 april 2029

Avslutad studie (Beräknad)

1 april 2029

Studieregistreringsdatum

Först inskickad

17 juni 2026

Först inskickad som uppfyllde QC-kriterierna

17 juni 2026

Första postat (Faktisk)

23 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2026

Senast verifierad

1 juni 2026

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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