QL1706+Lenvatinib+AG Regimen As First-line Treatment For Advanced Metastatic Pancreatic Cancer

Study Overview

QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer

The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 80 patients with advanced pancreatic cancer who have not received prior treatment. This study aims to enhance the anti-tumor immune effect through the combination of QL1706+Lenvatinib+AG regimen, thereby improving the prognosis of patients with advanced metastatic pancreatic cancer.

N/A

Advance Pancreatic Cancer

DRUG: QL1706+Lenvatinib+AG Regimen

2025-0462-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-07-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-20
First Submitted that Met QC Criteria 2025-07-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-08-27
First Posted (ESTIMATED) 2025-08-07	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: QL1706+Lenvatinib+AG Regimen	DRUG: QL1706+Lenvatinib+AG Regimen Participants will receive QL1706 combination with Lenvatinib and AG regimen for 8 cycles. Subsequently, the enrolled patients will continue to receive maintenance therapy with QL1706 and Lenvatinib until disease progression (PD) is observed, intolerable a

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: QL1706+Lenvatinib+AG Regimen

DRUG: QL1706+Lenvatinib+AG Regimen

Participants will receive QL1706 combination with Lenvatinib and AG regimen for 8 cycles. Subsequently, the enrolled patients will continue to receive maintenance therapy with QL1706 and Lenvatinib until disease progression (PD) is observed, intolerable a

Primary Outcome Measures	Measure Description	Time Frame
Median Progression-Free Survival (mPFS)		up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate (ORR)		up to 24 months
Disease Control Rate (DCR)		up to 24 months
Median Overall Survival (mOS)		up to 24 months
Adverse Events（AEs）		up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Juan Du

Phone Number: +86-13951826526

Email: dujuanglyy@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

a. Age ≥18 years, ECOG performance status ≤2, and expected survival of ≥3 months.
b. Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer.
c. At least one measurable lesion according to RECIST 1.1 criteria;
d. No prior anti-tumor treatment of any kind.
e. Patients must meet the following hematological criteria: e1. White blood cell count (WBC) ≥3.0×10^9/L; e2. Absolute neutrophil count (ANC) ≥1.5×10^9/L; e3. Hemoglobin (HB) ≥90 g/L; e4. Platelet count (PLT) ≥75×10^9/L; e5. Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); e6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; if there is liver metastasis, then ALT and AST ≤5×ULN; e7. Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr) ≥50 ml/min;
f. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
g. Patients of childbearing potential must take appropriate protective measures (contraception or other methods of fertility control) before enrollment and during the study.
h. Willingness to participate in the study, with signed informed consent, good compliance, and cooperation with follow-up; able to adhere to the study protocol and follow-up procedures.

a. Prior receipt of systemic anti-tumor treatment, such as chemotherapy, radiotherapy, or other anti-tumor treatments.
b. Participation in another drug clinical trial within the past 4 weeks.
c. Subjects who, in the investigator's judgment, have the opportunity for surgery or are potentially operable (subjects who voluntarily forgo surgical treatment may be enrolled after investigator assessment and agreement).
d. Subjects with moderate ascites requiring drainage (except for those with minimal ascites shown on imaging without symptoms).
e. Known symptomatic central nervous system metastases and/or carcinomatous meningitis.
f. History of other primary malignancies, except for the following: 1) Malignancies that have been in complete remission for at least 2 years prior to enrollment and do not require other treatments during the study; 2) Non-melanoma skin cancer or malignant lentigo that has been adequately treated and shows no evidence of disease recurrence; 3) Carcinoma in situ that has been adequately treated and shows no evidence of disease recurrence.
g. Patients with autoimmune diseases or immune deficiencies who are being treated with immunosuppressive drugs.
h. Patients with a tendency to bleed.
i. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
j. Drug abuse, or clinical, psychological, or social factors that may affect informed consent or study implementation.
k. Subjects who may be allergic to epaltrastide (QL1706), lenvatinib, albumin-bound paclitaxel, or gemcitabine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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