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

Phase 2

Not yet recruiting

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: QL1706; Drug: Chidamide; Drug: Gemcitabine; Drug: Nab-paclitaxel

• Registration Number: NCT06951997
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Study Start: 2025-05-15
• Primary Completion: 2027-05-15
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 33

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine	QL1706	QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine	Chidamide	QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine	Gemcitabine	QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine	Nab-paclitaxel	QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;

Primary Outcome Measures

Name	Time	Method
ORR	1 year	overall response rate

Secondary Outcome Measures

Name	Time	Method
OS	2 year	OS is defined as the time from date of treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
AEs	2 year	Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Progression-free Survival (PFS)	2 year	PFS was assessed by investigators per RECIST 1.1
Disease Control Rate (DCR)	2 year	DCR was assessed by investigators per RECIST 1.1
Duration of Response (DOR)	2 year	DOR was assessed by investigators per RECIST 1.1