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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanjing Drum Tower Hospital
  Nanjing, China Recruiting

Study contacts

• Study coordinator: Juan Du
• Email: dujuanglyy@163.com
• Phone: +86-13951826526

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• MRG003 added to ongoing treatment after progression in EGFR-positive advanced thyroid cancer

  In this study, researchers test whether adding MRG003 to a patient’s current thyroid cancer treatment can shrink tumors for those whose cancer initially responded but later progressed.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07874321

• Cryoablation with liver-directed immunotherapy and targeted therapy for melanoma liver metastases

  This trial tests a combination therapy including cryoablation, hepatic artery delivery of QL1706, intravenous dacarbazine, and oral lenvatinib to treat liver metastases from malignant melanoma in adults.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07847359

• BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

  This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.

  Recruiting at 2 sites Phase 3 BeOne Medicines · South Brisbane, Queensland and 1 other locations · NCT07836530

• Lenvatinib plus chemotherapy for pancreatic neuroendocrine tumors with liver metastases

  This study tests whether adding lenvatinib to chemotherapy helps people with pancreatic neuroendocrine tumors that have spread to the liver, after first-line therapy has stopped working.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07835893

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.