Advance Pancreatic CancerPhase 2NCT07110064
QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer
A Phase 2 study testing QL1706+Lenvatinib+AG Regimen in people with Advance Pancreatic Cancer, run by Du Juan at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Pancreatic Cancer
- What is being tested?
- QL1706+Lenvatinib+AG Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2025to 31 Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing
Juan Du, +86-13951826526, dujuanglyy@163.com
About this study
Official title: Iparomlimab and Tuvonralimab Injection (QL1706) in Combination With Lenvatinib and AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer:A Prospective, Single-Arm, Multicenter, Phase II Clinical Study
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.
- Conditions
- Advance Pancreatic Cancer
- Being tested
- QL1706+Lenvatinib+AG Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706+Lenvatinib+AG RegimenDrug
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 adverse events occur, or the investigator deems it inappropriate for the subject to continue treatment.
| Study group | Role | What they receive |
|---|---|---|
| QL1706+Lenvatinib+AG Regimen | Experimental | Not described Receives: Drug: QL1706+Lenvatinib+AG Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival (mPFS)
Measured: up to 24 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Measured: up to 24 months
Disease Control Rate (DCR)
Measured: up to 24 months
Median Overall Survival (mOS)
Measured: up to 24 months
Adverse Events（AEs）
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start3 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du Juan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Du Juan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110064
- Sponsor's protocol ID
- 2025-0462-02
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2025
- Last updated
- 2 Jan 2026
- Results posted
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab and Tuvonralimab Injection (QL1706) in Combination With Lenvatinib and AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer:A Prospective, Single-Arm, Multicenter, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07110064
- Acronym / sponsor ID
- 2025-0462-02
- Conditions
- Advance Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Du JuanUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Aug 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706+Lenvatinib+AG Regimen | Experimental | Drug: QL1706+Lenvatinib+AG Regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| QL1706+Lenvatinib+AG RegimenParticipants 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 adverse events occur, or the investigator deems it inappropriate for the subject to continue treatment. | Drug | QL1706+Lenvatinib+AG Regimen |
Primary outcome
Median Progression-Free Survival (mPFS)
Time frame: up to 24 months
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: up to 24 months
Median Overall Survival (mOS)
Time frame: up to 24 months
Adverse Events（AEs）
Time frame: up to 36 months
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 2 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site 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+Lenvatinib+AG Regimen in people with Advance Pancreatic Cancer, run by Du Juan at 1 site 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Juan Du (+86-13951826526, dujuanglyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression-Free Survival (mPFS) (time frame: up to 24 months). 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 2 Jan 2026.