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

NCT07386704 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: PRO-A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pancreatic Cancer Non-resectable

Keywords

locally advanced; oligometastasis

Outcome Measures

Primary Outcomes (1)

• LCR

  Local Control Rate

  The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy

Secondary Outcomes (2)

• OS

  The survival rates for 1 year, 2 years, and 5 years

• PFS

  Every 3 months

Study Arms (1)

Nimotuzumab + chemoradiotherapy group

EXPERIMENTAL

Drug: Nimotuzumab combined with chemoradiotherapy

Interventions

Nimotuzumab combined with chemoradiotherapy DRUG

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.

Nimotuzumab + chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed by histological or cytological examination as pancreatic adenocarcinoma;
• Confirmed by imaging as locally advanced or oligometastatic (number of metastatic lesions ≤ 3);
• Evaluated by the clinical doctor as inoperable or the patient refuses surgery;
• ECOG PS score 0-1;
• No radiotherapy has been performed on the upper abdomen before, and no any palliative chemotherapy or other systemic anti-tumor treatment has been received;
• According to the RECIST 1.1 evaluation criteria, there are measurable lesions;
• Sufficient organ and bone marrow functions

You may not qualify if:

• Previous history of abdominal radiotherapy.
• Those with a history of other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
• Those allergic to the drugs or their components used in this protocol.
• Those with known HIV or syphilis infection, or currently in the active stage of hepatitis (hepatitis B or hepatitis C).
• Those who have undergone major surgery within 30 days before screening.
• Those who have used EGFR monoclonal antibody or EGFR-TKI within 30 days before screening.
• Pregnant or lactating women.
• Those judged by the investigator to have other reasons unsuitable for participating in this study.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Department of Radiotherapy Oncology, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)