First-line QL1706 combined with lenvatinib and AG for advanced metastatic pancreatic cancer

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

This trial will test whether combining QL1706, lenvatinib, and gemcitabine plus nab‑paclitaxel (AG) works better as first-line treatment for people with advanced metastatic pancreatic cancer who have not had prior therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other)
• Drugs / interventions: lenvatinib, chemotherapy
• Locations: 1 site (Nanjing)
• Trial ID: NCT07110064 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter phase II study enrolling 80 patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer who have not received prior anti‑tumor treatment. Participants will receive a combination regimen of QL1706, the tyrosine kinase inhibitor lenvatinib, and the AG chemotherapy backbone. The combination is intended to enhance anti‑tumor immune effects while delivering standard cytotoxic therapy. Key outcomes will include tumor response, safety and tolerability, and measures related to patient prognosis.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with confirmed advanced metastatic pancreatic cancer, ECOG performance status ≤2, at least one measurable lesion, no prior systemic anti‑tumor therapy, and adequate blood, liver, kidney, and cardiac function as specified in the eligibility criteria.

Not a fit: Patients who have received prior anti‑tumor treatment, have poor performance status (>2), or who do not meet required organ function or cardiac criteria are unlikely to qualify for or benefit from this regimen.

Why it matters

Potential benefit: If successful, the regimen could improve tumor control and extend survival for some patients using a combined immunotherapy, targeted therapy, and chemotherapy approach.

How similar studies have performed: Combinations of immunotherapy, anti‑angiogenic agents, and chemotherapy have shown mixed results in pancreatic cancer and this specific QL1706 + lenvatinib + AG combination is relatively novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Nanjing

• Nanjing Drum Tower Hospital — Nanjing, China (RECRUITING)

Study contacts

• Study coordinator: Juan Du

Conditions: Advance Pancreatic Cancer