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

NCT06951997 | Recruiting Phase 2

• 1 other identifier: QL-PC-QIBA-3002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  1 year

Secondary Outcomes (5)

• OS

  2 year

• AEs

  2 year

• Progression-free Survival (PFS)

  2 year

• Disease Control Rate (DCR)

  2 year

• Duration of Response (DOR)

  2 year

Study Arms (1)

QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine

EXPERIMENTAL

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

Drug: QL1706; Drug: Chidamide; Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

QL1706 DRUG

5mg/kg, q3w

QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine

Chidamide DRUG

20mg, biw, q3w

QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine

Gemcitabine DRUG

1000mg/m2 Q3W

QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine

Nab-paclitaxel DRUG

125mg/m2 Q3W

QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign the informed consent form for this study
• Age ≥18 years and ≤ 75 years, ale or Female
• 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)
• No prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received
• At least one measurable lesion on imaging according to RECIST 1.1
• ECOG score 0-1
• Expected survival time ≥3 months
• 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
• Fertile women/non-sterilized men must use effective contraception

You may not qualify if:

• Inability to comply with the study protocol or procedures
• patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors
• Known presence of germline BRCA1/2 mutations
• patients with known central nervous system metastases
• Hypersensitivity or allergic predisposition to the study drug or its excipients
• Concurrent use of any other investigational drug or participation in another clinical trial involving investigational therapy within 4 weeks
• Major surgery, severe traumatic injury, fractures, or ulcers within 6 weeks before study
• 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
• Clinically significant gastrointestinal disorders, including obstruction (including partial), dysphagia, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other conditions severely affecting nutrient absorption
• Clinically significant bleeding or clear bleeding tendency within 1 month before the first dose, e.g.,gastrointestinal bleeding, hemorrhagic gastric ulcer
• 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
• History of other malignancies within 5 years before enrollment, except for adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ
• Any cardiovascular or cerebrovascular disease or risk factors
• Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment
• Prior allogeneic bone marrow or solid organ transplantation

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Gemcitabine; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Rui Liu

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Rui Liu, MD

CONTACT

13602139003; liurui9003@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-03

Locations

CN (1)