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Recruiting NCT06941766

Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors

Phase I / Phase II Interventional Intermediate Trophoblastic Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QL1706, Chemotherapy.
Who it may be relevant to
Registry conditions: Intermediate Trophoblastic Tumor. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) in the Treatment of Intermediate Trophoblastic Tumors: A Prospective, Multicenter, Single-arm Trial

Overview

This clinical trial aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706), a dual-targeting immunotherapy (anti-PD-1/CTLA-4), in patients with intermediate trophoblastic tumors (ITT). The main questions it aims to answer are: Does QL1706 improve complete response (CR) rates (primary endpoint) and survival outcomes? What are the safety profiles of QL1706 in ITT, including immune-related adverse events? Participants will receive QL1706 (5 mg/kg IV, Q3W) ± chemotherapy (FAEV/EMA/EP/EMA/CO/TP-TE). They will also receive Maintenance therapy post-hCG normalization. Efficacy is assessed via serial β-hCG tests, imaging (every 9-12 weeks), and biomarker analysis.

Interventions

  • Drug QL1706
    5 mg/kg, IV infusion, Q3W (D1)
  • Drug Chemotherapy
    FAEV, EMA/EP, EMA/CO, or TP/TE.

Primary outcome measures

  • Complete Response (CR) Rate [Time frame: up to one year]
Secondary outcome measures (9)
  • Objective Response Rate (ORR) [Time frame: up to one year]
  • Disease Control Rate (DCR) [Time frame: up to one year]
  • Rate of Progression-Free Survival (PFS) [Time frame: up to one year]
  • Rate of Overall Survival (OS) [Time frame: up to one year]
  • Concentration of anti-Müllerian hormone (AMH) to assess ovarian function [Time frame: up to one year]
  • Number of Participants with treatment-related Adverse Events [Safety and Tolerability] [Time frame: up to one year]
  • Quality of life of cancer patients by questionnaire [Time frame: up to one year]
  • Cancer specific rehabilitation by questionnaire [Time frame: up to one year]
  • Reproductive concerns after cancer by scale [Time frame: up to one year]

Eligibility criteria

Inclusion criteria

Females aged 18-70 years. Histologically confirmed placental site trophoblastic tumor (PSTT) or epitheloid trophoblastic tumor (ETT)

For Cohort A:

Stage IV disease (treatment-naïve）, recurrent, or chemotherapy-resistant disease

For Cohort B:

Stage I-III disease requiring adjuvant chemotherapy post-biopsy/surgery, meeting ≥1 of: Abnormal β-hCG 2 weeks post-surgery; Incomplete resection; High-risk features includes: Interval from last pregnancy ≥48 months; Deep myometrial invasion; Mitotic count >5/HPF; Tumor necrosis.

ECOG score 0-1. Signed informed consent.

Organ Function Requirements:

Hematologic:

WBC ≥3.0×10⁹/L ANC ≥1.5×10⁹/L Platelets ≥80×10⁹/L Hemoglobin ≥8.0 g/dL Creatinine ≤1.5×ULN Total bilirubin ≤1.5×ULN (or direct bilirubin ≤ULN if total bilirubin >1.5×ULN) AST/ALT ≤2.5×ULN INR/PT/aPTT ≤1.5×ULN (or within therapeutic range if on anticoagulants).

Exclusion criteria

Life expectancy <3 months. Non-gestational trophoblastic tumors. Active malignancy (except if cured ≥3 years prior). Prior immune checkpoint therapy (anti-PD-1/L1, CTLA-4, ICOS, CD40, etc.) or cell-based immunotherapies.

Active autoimmune disease requiring systemic treatment (past 2 years). Exceptions: Hormone replacement (e.g., thyroxine), physiologic corticosteroids (≤10 mg/day prednisone equivalent).

Active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis). Systemic corticosteroids (>10 mg/day prednisone equivalent) within 14 days. Allowed: Topical/inhaled steroids, prophylactic steroids for contrast allergy.

HIV/AIDS.

Active hepatitis:

HBV DNA >1,000 IU/mL (unless on stable antiviral therapy with DNA <1,000 IU/mL).

HCV RNA-positive (unless cured). Active tuberculosis (screening required if suspected). Uncontrolled severe infection (e.g., sepsis, pneumonia requiring hospitalization).

Cardiovascular disease: NYHA Class III/IV heart failure or LVEF <50%. Uncontrolled hypertension (≥140/90 mmHg despite treatment). Unstable angina, myocardial ischemia, or arterial thromboembolism (≤6 months).

Interstitial lung disease (history or active). Malabsorption syndromes (e.g., chronic diarrhea, bowel obstruction) or GI perforation/fistula (≤6 months).

Psychiatric/social conditions impairing consent or compliance. Allogeneic transplant history. Live vaccines ≤30 days prior to QL1706 or planned during study. Hypersensitivity to monoclonal antibodies or protocol-specified chemotherapies. Pregnancy/lactation. Other conditions deemed to compromise patient safety or study integrity.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06941766 · ITT01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗