NCT06313970 First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients
| NCT ID | NCT06313970 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2025-10-31 |
Trial Parameters
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. Subjects voluntarily participate in this study, sign the informed consent form; 2. Age ≥18 years and ≤75 years; 3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or adenocarcinoma. 4. Patients have not received prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6. ECOG Performance Status 0-1; 7. Estimated life expectancy ≥3 months; 8. Adequate major organ function (no medication for blood component, cell growth factor correction therapy is allowed within 14 days before randomization); 9. Women of child-bearing potential must agree to use a reliable, effective method of contraception from the time they provide informed consent until at least 120 days after the last dose of study drug is administered. HCG test must be negative. And must be non-lactating; 10. Male participants whose partner is a woman of child-bearing potential must
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