QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC (NCT06750861) | Clinical Trial Compass
Not Yet RecruitingPhase 2
QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC
China30 participantsStarted 2025-02-15
Plain-language summary
This is a single-center, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18, male or female;
✓. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
✓. Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
✓. Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
✓. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
✓. Has a life expectancy of at least 3 months;
✓. Has adequate organ function;
✓. If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
Exclusion criteria
✕. Untreated active CNS metastasis or leptomeningeal metastasis.
✕. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
✕. Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
✕
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 1 year
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: 1 year
Trial details
NCT IDNCT06750861
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
✕. Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
✕. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \< 10 mg prednisone daily, inhaled steroids and topical use of steroids);
✕. Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
✕. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;