First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients

NCT06313970 | Recruiting Phase 2

• 1 other identifier: QLMA-PC-IIT-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the percentage of subjects with complete response (CR) or partial response (PR) by investigator assessment per RECIST criteria, version 1.1.

  up to approximately 1 years

Secondary Outcomes (6)

• Disease control rate (DCR)

  up to approximately 1 years

• Duration of Response (DoR)

  up to approximately 1 years

• Time to response(TTR)

  up to approximately 1 years

• Progression-free survival (PFS)

  up to approximately 1 years

• Overall survival（OS）

  up to approximately 1 years

Study Arms (2)

QL1706+chemotherapy

EXPERIMENTAL

QL1706 administered by intravenous infusion, 5 mg/kg, administered once every 3 weeks, every 3 weeks as a cycle; Albumin paclitaxel administered by intravenous infusion, 125 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; Gemcitabine IV infusion over 30 min, 1000 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; On day 1 of each cycle, drugs were administered in the following order: ql1706 → albumin paclitaxel → gemcitabine. The first dose was administered within 2 days of randomization, and subjects used the study drug until protocol-specified criteria for treatment termination were present.

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

QL1706+chemotherapy+ bevacizumab

EXPERIMENTAL

QL1706 administered by intravenous infusion, 5 mg/kg, administered once every 3 weeks, every 3 weeks as a cycle; Bevacizumab administered by intravenous infusion, 7.5 mg/kg, administered once every 3 weeks, every 3 weeks as a treatment cycle; Albumin paclitaxel administered by intravenous infusion, 125 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; Gemcitabine IV infusion over 30 min, 1000 mg/m2, administered on Days 1 and 8, 1 treatment cycle every 3 weeks; On day 1 of each cycle, drugs were administered in the following order: ql1706 → bevacizumab → albumin paclitaxel → gemcitabine. The first dose was administered within 2 days of randomization, and subjects used the study drug until protocol-specified criteria for treatment termination were present.

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

Interventions

QL1706 DRUG

QL1706 5mg/kg，IV，D1, Q3W

QL1706+chemotherapy; QL1706+chemotherapy+ bevacizumab

Nab-paclitaxel DRUG

Nab-paclitaxel, 125mg/m2，IV，D1、8, Q3W

QL1706+chemotherapy; QL1706+chemotherapy+ bevacizumab

Gemcitabine DRUG

gemcitabine，1000mg/m2，IV，D1、8；Q3W.

QL1706+chemotherapy; QL1706+chemotherapy+ bevacizumab

Bevacizumab DRUG

bevacizumab, 7.5mg/kg，IV，D1；Q3W.

QL1706+chemotherapy+ bevacizumab

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participate in this study, sign the informed consent form;
• Age ≥18 years and ≤75 years;
• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or adenocarcinoma.
• Patients have not received prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer;
• At least one measurable lesion according to RECIST 1.1 criteria;
• ECOG Performance Status 0-1;
• Estimated life expectancy ≥3 months;
• Adequate major organ function (no medication for blood component, cell growth factor correction therapy is allowed within 14 days before randomization);
• 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;
• Male participants whose partner is a woman of child-bearing potential must agree to use a reliable, effective method of contraception from the time they sign an informed consent form until at least 120 days after the last dose of study drug is administered. Male subjects also have to agree not to donate sperm during the same period.

You may not qualify if:

• Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
• Patients with other malignant tumors within 5 years, except localized tumor that has been cured;
• Known active or untreated brain metastases, meningeal metastases, spinal cord compression or leptomeningeal disease.
• Patients with a history of life-threatening bleeding or a definite risk of bleeding within 6 months before randomization;
• Has undergone major trauma or surgical treatment within 28 days before randomization or is expected to undergo major surgical treatment during the study period;
• Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) ；or have a history of hypertensive crisis or hypertensive encephalopathy;
• Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc., occurred within 6 months before randomization;
• Patients who receive any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint blockades, immune checkpoint agonists, immune cell therapy, etc.
• Active autoimmune disease requiring systemic treatment within 2 years before randomization, or autoimmune diseases that may relapse or require scheduled treatment judged by the investigator;
• Subjects with active hepatitis B or C;
• Patients with a known history of immunodeficiency or HIV positive;
• The investigator assessed that it is not appropriate to participate in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine; Bevacizumab

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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Si Shi, MD

CONTACT

+86-021-64179375; shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 15, 2024
• Study Start: June 20, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)