NCT07386704

Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer

A Prospective, Single-arm Study of Nimotuzumab Combined With Radiotherapy and Chemotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm trial, aiming to enroll 30 patients with unresectable locally advanced or oligometastatic pancreatic cancer. The study will evaluate the efficacy and safety of nintedanib combined with radiotherapy and chemotherapy (gemcitabine or capecitabine monotherapy). The primary endpoint of this study is the 1-year local control rate (LCR).

Detailed description

1\. Radiotherapy: Conventional fractionated radiotherapy or SBRT can be selected. 1. Conventional Fractionated Radiotherapy: Pancreatic tumor + 5mm PTV 50-60Gy/25 fractions/5W; Pancreatic tumor GTV 60-70Gy/25 fractions/5W; If there are suspected metastatic lymph node regions, prophylactic irradiation of lymph node drainage areas should be performed. 2. Stereotactic Body Radiotherapy (SBRT): Pancreatic tumor + 5mm PTV 30Gy/5 fractions/5 days; Pancreatic tumor GTV 40Gy/5 fractions/5 days. 2\. Nintuzumab: Nintuzumab 400mg, intravenous infusion, on day 1, administered once a week (QW). Mix400 mg of nintuzumab injection with 250ml of sodium chloride solution, and the infusion time should be more than 60 minutes. Administer concurrently during radiotherapy and discontinue use after radiotherapy. 3\. Chemotherapy (either tegafur or capecitabine, choose one): 1. Tegafur-gimeracil-oteracil (S-1): 80-120mg per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days. 2. Capecitabine: 2000mg per square meter per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days. Continue the treatment until the disease progresses or an intolerable toxic reaction occurs.

Conditions

• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
DRUG	Nimotuzumab combined with chemoradiotherapy	The patient received treatment with nimotuzumab combined with radiotherapy and chemotherapy. The radiotherapy could be conducted using conventional fractionated radiotherapy or SBRT, and the chemotherapy could be carried out using tegafur or capecitabine.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-12-09
• Completion: 2027-12-09
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: China