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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Pancreatic Cancer Non-resectable
• Intervention / Treatment: Drug: Nimotuzumab combined with chemoradiotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Department of Radiotherapy Oncology, Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nimotuzumab + chemoradiotherapy group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LCR	Local Control Rate	The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	The survival rates for 1 year, 2 years, and 5 years
PFS	Progression-free survival	Every 3 months

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: locally advanced; oligometastasis
• Additional Relevant MeSH Terms: Therapeutics; Drug Therapy; Radiotherapy; Combined Modality Therapy; Chemoradiotherapy
• Other Study ID Numbers: PRO-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No