Clinical trial · Interventional
QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC
QL1706 in Combination With Nab-paclitaxel and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study
NCT06750861CI-TRIAL-00085732not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QL1706+AG
- description
- QL1706+AG Every 3 weeks as a cycle: QL1706: 5mg/kg, IV, D3; Q3W Nab-paclitaxel: 125mg/m2, IV,D1、8; Q3W Gemcitabine: 1000mg/m2,IV,D1、8; Q3W Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is QL1706 monotherapy.
- interventionNames
- Drug: QL1706
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 1 year
- description
- ORR of regimen of QL1706+AG
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18, male or female; 2. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC); 3. Has not received prior systemic treatment for their locally advanced or metastatic PDAC; 4. Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1); 5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status; 6. Has a life expectancy of at least 3 months; 7. Has adequate organ function; 8. If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment; 9. If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment. Exclusion Criteria: 1. Untreated active CNS metastasis or leptomeningeal metastasis. 2. 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; 3. 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; 4. 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; 5. 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; 6. 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); 7. Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines); 8. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management; 9. History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; 10. Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug; 11. Is pregnant or breastfeeding; 12. Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.