A Phase 2 interventional study of QL1706 and Nab-paclitaxel in Pancreatic Cancer, sponsored by Fudan University. Active, not recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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
This study is an open, multicenter, exploratory clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with albumin paclitaxel and gemcitabine with or without bevacizumab for the first-line treatment of patients with unresectable locally advanced or metastatic pancreatic cancer.
The study was conducted in patients with unresectable locally advanced or metastatic pancreatic cancer who had not received prior systemic therapy. Subjects sign informed consent, undergo a screening period of examination and evaluation, which lasts for 21 days, and those who meet the entry criteria enter the treatment period and are randomized 1:1 to receive either QL1706 in combination with albumin paclitaxel and gemcitabine or to receive QL1706 in combination with albumin paclitaxel, gemcitabine, and bevacizumab in 3-week intervals until protocol-specified treatment termination Event. Subjects will be enrolled in the study and will undergo a safety visit prior to D1 dosing for each treatment cycle, please refer to the trial flow chart. Imaging exams and assessments will be performed every 6 weeks (± 7 days) for the first 24 weeks of treatment and every 9 weeks (± 7 days) thereafter until disease progression, initiation of new antitumor therapy, withdrawal of informed consent, or death, whichever occurs first, as confirmed per RECIST v1.1. Additional imaging and evaluation may be performed at any time during the study if clinically indicated.
Subjects will be required to complete safety examinations and imaging assessments at the end of treatment, followed by a safety visit and follow-up until 90 days after the last dose of QL1706 or 30 days after the last dose of other investigational agents, whichever is longer. For subjects who end treatment with non-RECIST v1.1 criteria for disease progression, imaging should be continued to assess time to tumor progression. Survival follow-up is performed after the safety visit, every 60 days (±7 days), to collect and record the subject's survival status and subsequent antitumor therapy.
The study used ORR as the primary endpoint and was planned to enroll 58 subjects, 29 in the QL1706 combined albumin paclitaxel and gemcitabine group and 29 in the QL1706 combined albumin paclitaxel and gemcitabine combined bevacizumab group.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 58 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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
QL1706 5mg/kg，IV，D1, Q3W
Nab-paclitaxel, 125mg/m2，IV，D1、8, Q3W
gemcitabine，1000mg/m2，IV，D1、8；Q3W.
bevacizumab, 7.5mg/kg，IV，D1；Q3W.
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.
Time frame: up to approximately 1 years
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD).Version 1.3 added DCR assessed per iRECIST.
Time frame: up to approximately 1 years
Duration of Response (DoR)
Response will be determined by investigator using RECIST 1.1. Version 1.3 added DoR assessed per iRECIST.
Time frame: up to approximately 1 years
Time to response(TTR)
Response will be determined by investigator using RECIST 1.1.Version 1.3 added TTR assessed per iRECIST.
Time frame: up to approximately 1 years
Progression-free survival (PFS)
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.Version 1.3 added PFS assessed per iRECIST.
Time frame: up to approximately 1 years
Overall survival（OS）
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: up to approximately 1 years
Adverse Events
AE assessed by NCI-CTCAE v5.0.
Time frame: up to approximately 1 years
ORR
Version 1.3 added ORR assessed per iRECIST.
Time frame: up to approximately 1 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fudan University