LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study

NCT07312422 | Recruiting Phase 1 DMC

• 1 other identifier: Pucotenlimab in PDAC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the activating effect of local lesion low-dose radiotherapy (2Gy) on the tumor immune microenvironment, and the efficacy, safety, and feasibility of its combination with pembrolizumab and standard therapy in patients with advanced pancreatic cancer. Concurrently, to preliminarily establish an efficacy prediction model for the early identification of patient populations who would benefit from the treatment, thereby providing a theoretical foundation for the implementation of precision medicine.

Conditions

Pancreatic Cancer; PD-L1; PD-1 Inhibitor; LDRT; Proterizumab

Keywords

pancreatic cancer; PD-1 inhibitor; LDRT; immunotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  Overall objective tumor response rate

  6 weeks

Secondary Outcomes (2)

• DCR

  2 years

• PFS

  2 years

Study Arms (1)

LDRT + Pucotenlimab + Chemotherapy

EXPERIMENTAL

Patients will receive low-dose radiotherapy (2Gy/1fx) on Day 1 of each cycle. On Day 2, patients will receive Pucotenlimab (200mg IV) combined with standard chemotherapy (investigator's choice of AG regimen or FOLFIRINOX regimen). Treatment cycles differ slightly based on the chemotherapy regimen chosen but are generally repeated every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or up to 2 years.

Radiation: Low-dose Radiotherapy; Biological: Pucotenlimab; Drug: AG regimen; Drug: FOLFIRINOX regimen

Interventions

FOLFIRINOX regimen DRUG

Oxaliplatin (65 mg/m\^2), Irinotecan (140 mg/m\^2), Leucovorin (400 mg/m\^2) on Day 1, followed by 5-FU (2400 mg/m\^2) continuous infusion over 46 hours, every 3 weeks.

LDRT + Pucotenlimab + Chemotherapy

Low-dose Radiotherapy RADIATION

Administered on Day 1 of each cycle. A single fraction of 2 Gy (2Gy/1fx) is delivered to the measurable tumor lesion using 3D-CRT or IMRT techniques.

LDRT + Pucotenlimab + Chemotherapy

Pucotenlimab BIOLOGICAL

Administered intravenously (200 mg) on Day 2 of each cycle, every 3 weeks (q3w).

LDRT + Pucotenlimab + Chemotherapy

AG regimen DRUG

Gemcitabine (1000 mg/m\^2) and Nab-paclitaxel (125 mg/m\^2) administered intravenously on Day 1 and Day 8 of each 3-week cycle.

LDRT + Pucotenlimab + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Liu Yang, M.D.

CONTACT

13666601475; yangliuqq2003@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 31, 2025
• Study Start: September 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)