QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer

NCT ID: NCT06951997

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2027-12-31

Brief Summary

This is a single-center, open-label, exploratory study aims to assess the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment for patients with metastatic pancreatic adenocarcinoma.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine

QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;

Group Type: EXPERIMENTAL

QL1706

Intervention Type: DRUG

5mg/kg, q3w

Chidamide

Intervention Type: DRUG

20mg, biw, q3w

Gemcitabine

Intervention Type: DRUG

1000mg/m2 Q3W

Nab-paclitaxel

Intervention Type: DRUG

125mg/m2 Q3W

Interventions

QL1706

5mg/kg, q3w

Intervention Type: DRUG

Chidamide

20mg, biw, q3w

Intervention Type: DRUG

Gemcitabine

1000mg/m2 Q3W

Intervention Type: DRUG

Nab-paclitaxel

125mg/m2 Q3W

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1、Understand and voluntarily sign the informed consent form for this study; 2、Age ≥18 years and ≤ 75 years, ale or Female; 3、Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer); 4、No prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received; 5、（1）At least one measurable lesion on imaging according to RECIST 1.1; 6、ECOG score 0-1; 7、Expected survival time ≥3 months; 8、Adequate organ function, subjects must meet the following laboratory criteria:

• Platelet count ≥90x10^9/L
• White blood cell count ≥ 3.5 × 10⁹/L
• Absolute neutrophil count (ANC) ≥1.5x10^9/L
• Hemoglobin > 90g/L
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN;
• Total bilirubin ≤ 1.5 ULN;
• Urea/Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL/min);
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• QTcF interval (Fridericia correction) < 470 ms; 9、Fertile women/non-sterilized men must use effective contraception.

Exclusion Criteria

• 1 Inability to comply with the study protocol or procedures； 2 patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors; 3 Known presence of germline BRCA1/2 mutations； 4 patients with known central nervous system metastases; 5 Hypersensitivity or allergic predisposition to the study drug or its excipients; 6 Concurrent use of any other investigational drug or participation in another clinical trial involving investigational therapy within 4 weeks; 7 Major surgery, severe traumatic injury, fractures, or ulcers within 6 weeks before study； 8 History of gastrointestinal perforation or fistula within 6 months before the first dose. Subjects may be enrolled if the perforation/fistula has been surgically repaired and the investigator confirms resolution; 9 Clinically significant gastrointestinal disorders, including obstruction (including partial), dysphagia, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other conditions severely affecting nutrient absorption; 10 Clinically significant bleeding or clear bleeding tendency within 1 month before the first dose, e.g.,gastrointestinal bleeding, hemorrhagic gastric ulcer; 11 Any of the following concurrent conditions;

1. Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure;

2. Severe uncontrolled concurrent infection causing disability.

3. Proteinuria ≥ 2+ (≥1.0 g/24 h);

4. Bleeding tendency or history within 2 months before enrollment, regardless of severity;

5. Arterial/venous thromboembolic events within 12 months before treatment (e.g., cerebrovascular accident, transient ischemic attack);

6. Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment;

7. Unhealed fractures or chronic wounds;

8. Coagulopathy, bleeding tendency, or ongoing anticoagulation therapy; 12、History of other malignancies within 5 years before enrollment, except for adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ; 13、Any cardiovascular or cerebrovascular disease or risk factors. 14、Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment; 15、Prior allogeneic bone marrow or solid organ transplantation; 16、Unresolved toxicities (> CTCAE v5.0 Grade 1) from prior anticancer therapy, except alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity (≤ Grade 2); 17、Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4 antibodies), immune checkpoint agonists (e.g., anti-ICOS/CD40/CD137/GITR/OX40 antibodies), or immune cell therapy (e.g., CAR-T); 18、Systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before the first dose; 19、Known interstitial lung disease (ILD) or non-infectious pneumonitis (either symptomatic or requiring systemic steroids); 20、Any other clinically significant condition, metabolic disorder, physical/lab abnormality, epilepsy requiring treatment etal; 21、Pregnant or breastfeeding women; 22、Any other condition deemed unsuitable for study participation by the investigator;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Liu

Role: STUDY_CHAIR

Tianjin Medical University Cancer Institute and Hospital

Central Contacts

Rui Liu, MD

Role: CONTACT

Phone: 13602139003

Email: liurui9003@163.com

Other Identifiers

QL-PC-QIBA-3002

Identifier Type: -

Identifier Source: org_study_id