Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer

July 8, 2026 updated by: Changhai Hospital

An Exploratory Clinical Study of HRS-4642 in Combination With Chemotherapy With or Without Adebrelimab as Neoadjuvant Therapy for Pancreatic Cancer

To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female participants aged 18-70 (including those who are 18 and 70 years old)；
  2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
  3. Life expectancy ≥ 12 weeks;
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  5. Adequate marrow and organ function;

Exclusion Criteria:

  1. Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy;
  2. Presence of distant metastatic lesions confirmed by imaging;
  3. Known hypersensitivity to the investigational drug or any of its excipients;
  4. Presence of any serious or uncontrolled systemic disease;
  5. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
  6. Clinically significant acute or chronic pancreatitis;
  7. Participation in any interventional clinical trial involving drugs or medical devices within 4 weeks prior to the first administration of study treatment;
  8. Vaccination with live or live-attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
  9. Any other condition that, in the judgment of the investigator, makes the subject unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1：HRS-4642+NALIRIFOX
Drug: HRS-4642+NALIRIFOX
HRS-4642+NALIRIFOX
Experimental: Arm 2：HRS-4642+NALIRIFOX+Adebrelimab（4 cycles of neoadjuvant therapy）
Drug: HRS-4642+NALIRIFOX+Adebrelimab
HRS-4642+NALIRIFOX+Adebrelimab
Experimental: Arm 3：HRS-4642+NALIRIFOX+Adebrelimab（6 cycles of neoadjuvant therapy）
Drug: HRS-4642+NALIRIFOX+Adebrelimab
HRS-4642+NALIRIFOX+Adebrelimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose
From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
Time Frame: Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months
Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pathologic Complete Response Rate (pCR)
Time Frame: At the time of surgery
At the time of surgery
R0 (microscopically margin-negative) resection rate
Time Frame: At the time of surgery
At the time of surgery
Major Pathologic Response Rate (MPR)
Time Frame: At the time of surgery
At the time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANC-HRS4642-SHR1316-NALIRIFOX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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