Pancreatic CancerPhase 2NCT06313970
First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients
A Phase 2 study testing QL1706, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Fudan University at 3 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- QL1706, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesChina
- Study dates
- 20 Jun 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Fudan University Shanghai Cancer Center
Shanghai
The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)
Shanghai
About this study
Official title: A Multicenter,Open-label,Exploratory Study 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 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
Read the detailed description
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.
- Conditions
- Pancreatic Cancer
- Being tested
- QL1706, Nab-paclitaxel, Gemcitabine, Bevacizumab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
QL1706 5mg/kg，IV，D1, Q3W
Nab-paclitaxelDrug
Nab-paclitaxel, 125mg/m2，IV，D1、8, Q3W
GemcitabineDrug
gemcitabine，1000mg/m2，IV，D1、8；Q3W.
BevacizumabDrug
bevacizumab, 7.5mg/kg，IV，D1；Q3W.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: QL1706; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to approximately 1 years
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to approximately 1 years
Adverse Events
AE assessed by NCI-CTCAE v5.0.
Measured: up to approximately 1 years
ORR
Version 1.3 added ORR assessed per iRECIST.
Measured: up to approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Jun 2024
- Primary completion4 Dec 2025
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, Shanghai Changzheng Hospital
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313970
- Sponsor's protocol ID
- QLMA-PC-IIT-001
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter,Open-label,Exploratory Study 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
- ClinicalTrials.gov ID
- NCT06313970
- Acronym / sponsor ID
- QLMA-PC-IIT-001
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Huadong Hospital, Shanghai Changzheng Hospital
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706+chemotherapy | Experimental | Drug: QL1706, Drug: Nab-paclitaxel, Drug: GemcitabineQL1706 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. |
| QL1706+chemotherapy+ bevacizumab | Experimental | Drug: QL1706, Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: BevacizumabQL1706 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1706QL1706 5mg/kg，IV，D1, Q3W | Drug | QL1706+chemotherapy, QL1706+chemotherapy+ bevacizumab |
| Nab-paclitaxelNab-paclitaxel, 125mg/m2，IV，D1、8, Q3W | Drug | QL1706+chemotherapy, QL1706+chemotherapy+ bevacizumab |
| Gemcitabinegemcitabine，1000mg/m2，IV，D1、8；Q3W. | Drug | QL1706+chemotherapy, QL1706+chemotherapy+ bevacizumab |
| Bevacizumabbevacizumab, 7.5mg/kg，IV，D1；Q3W. | Drug | QL1706+chemotherapy+ bevacizumab |
Primary outcome
Objective response rate (ORR)
Time frame: up to approximately 1 years
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.
7 secondary outcomes
Disease control rate (DCR)
Time frame: up to approximately 1 years
Duration of Response (DoR)
Time frame: up to approximately 1 years
Time to response(TTR)
Time frame: up to approximately 1 years
Progression-free survival (PFS)
Time frame: up to approximately 1 years
Overall survival（OS）
Time frame: up to approximately 1 years
Adverse Events
Time frame: up to approximately 1 years
ORR
Time frame: up to approximately 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Pancreatic Cancer
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Fudan University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to approximately 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.