Low-dose local radiotherapy plus pucotenlimab with standard chemotherapy for advanced 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 single-arm Phase 1/2 study gives patients with advanced pancreatic cancer a short course of low-dose (2 Gy) local radiotherapy to a target lesion combined with the PD-1 inhibitor pucotenlimab and standard systemic chemotherapy (AG or FOLFIRINOX). The trial will monitor safety, feasibility, and anti-tumor activity while collecting tissue and immune markers to see how the radiation changes the tumor immune microenvironment. Investigators will also build a preliminary prediction model to try to identify which patients are most likely to benefit. Primary goals are to define tolerability and early signals of efficacy to guide larger trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years, regardless of gender;
* ECOG score of 0 to 1;
* Patients with histologically or cytologically confirmed pancreatic malignancy;
* No prior treatment with PD-1 or PD-L1 inhibitors;
* Presence of a radiotherapeutically eligible target lesion (excluding bone metastases);
* Subjects voluntarily participate in the study and provide signed informed consent.

Exclusion Criteria:

* Previous history of radiotherapy;
* Uncontrolled chronic infectious or non-infectious diseases, including but not limited to: medication-refractory heart failure, poorly controlled hypertension, etc.;
* Active or clinically uncontrolled severe infections;
* History of psychoactive drug abuse that cannot be abstained from, or patients with psychiatric disorders;
* Pregnant or lactating women, or patients of childbearing potential who are unwilling or unable to adopt effective contraceptive measures;
* Other conditions deemed by the investigator as potentially affecting the conduct of the clinical study or the interpretation of study results.

Where it's running

• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Liu Yang, M.D.
• Email: yangliuqq2003@163.com
• Phone: 13666601475

Similar studies

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

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

  This pilot test uses contrast-enhanced ultrasound to see if it can help detect return of pancreatic cancer after surgery in patients being watched with CT scans.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07910383

• Pucotenlimab and Anlotinib with Chemo Before Surgery for Early-Stage Triple-Negative Breast Cancer

  This study tests a combo of pucotenlimab, anlotinib, and nab-paclitaxel before surgery in adults with newly diagnosed, stage II-III triple-negative breast cancer that is PD-L1 known.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou · NCT07896668

• Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

  This study tests whether adding ivermectin to standard preventive skin care helps people with pancreatic cancer who develop skin side effects from daraxonrasib.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895498

• Becotatug Vedotin Plus Anti-PD-1 and S-1 in EGFR-Positive Advanced Pancreatic Cancer

  This study tests a three-drug regimen (becotatug vedotin, an anti-PD-1 therapy, and S-1) in adults with EGFR-positive advanced pancreatic cancer who have not responded to at least one prior therapy.

  Recruiting Ningbo Medical Center Lihuili Hospital · Ningbo, Zhejiang · NCT07892573

• Becotatug Vedotin plus Pucotenlimab for EGFR-positive metastatic colorectal cancer

  This study tests whether combining becotatug vedotin with pucotenlimab can shrink tumors in adults with colorectal cancer that has returned or spread after at least two prior treatments and whose tumors express EGFR.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07884188

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.