First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients

Sponsor
Fudan University
Study ID
NCT06313970
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • QL1706 — DRUG
    QL1706 5mg/kg，IV，D1, Q3W
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel, 125mg/m2，IV，D1、8, Q3W
  • Gemcitabine — DRUG
    gemcitabine，1000mg/m2，IV，D1、8；Q3W.
  • Bevacizumab — DRUG
    bevacizumab, 7.5mg/kg，IV，D1；Q3W.

Study Details

This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer

Key Dates

First listed
Mar 15, 2024
Start date
Jun 20, 2024
Status verified
Sep 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706+chemotherapy
    QL1706 administered by intravenous infusion, 5 mg/kg, administered once every 3 weeks, every 3 weeks as a cycle; Albumin paclitaxel administered by intravenous infusion, 125 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; Gemcitabine IV infusion over 30 min, 1000 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; On day 1 of each cycle, drugs were administered in the following order: ql1706 → albumin paclitaxel → gemcitabine. The first dose was administered within 2 days of randomization, and subjects used the study drug until protocol-specified criteria for treatment termination were present.
  • Experimental: QL1706+chemotherapy+ bevacizumab
    QL1706 administered by intravenous infusion, 5 mg/kg, administered once every 3 weeks, every 3 weeks as a cycle; Bevacizumab administered by intravenous infusion, 7.5 mg/kg, administered once every 3 weeks, every 3 weeks as a treatment cycle; Albumin paclitaxel administered by intravenous infusion, 125 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; Gemcitabine IV infusion over 30 min, 1000 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; On day 1 of each cycle, drugs were administered in the following order: ql1706 → bevacizumab → albumin paclitaxel → gemcitabine. The first dose was administered within 2 days of randomization, and subjects used the study drug until protocol-specified criteria for treatment termination were present.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to approximately 1 years ]

Central Contacts

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