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

NCT07691593 | Not Yet Recruiting Phase 2

• 1 other identifier: PANC-HRS4642-SHR1316-NALIRIFOX
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  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)

  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 Outcomes (3)

• Pathologic Complete Response Rate (pCR)

  At the time of surgery

• R0 (microscopically margin-negative) resection rate

  At the time of surgery

• Major Pathologic Response Rate (MPR)

  At the time of surgery

Study Arms (3)

Arm 1：HRS-4642+NALIRIFOX

EXPERIMENTAL

Drug: HRS-4642+NALIRIFOX

Arm 2：HRS-4642+NALIRIFOX+Adebrelimab（4 cycles of neoadjuvant therapy）

EXPERIMENTAL

Drug: HRS-4642+NALIRIFOX+Adebrelimab

Arm 3：HRS-4642+NALIRIFOX+Adebrelimab（6 cycles of neoadjuvant therapy）

EXPERIMENTAL

Drug: HRS-4642+NALIRIFOX+Adebrelimab

Interventions

HRS-4642+NALIRIFOX DRUG

HRS-4642+NALIRIFOX

Arm 1：HRS-4642+NALIRIFOX

HRS-4642+NALIRIFOX+Adebrelimab DRUG

HRS-4642+NALIRIFOX+Adebrelimab

Arm 2：HRS-4642+NALIRIFOX+Adebrelimab（4 cycles of neoadjuvant therapy）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 18-70 (including those who are 18 and 70 years old)；
• 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);
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Adequate marrow and organ function;

You may not qualify if:

• 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;
• Presence of distant metastatic lesions confirmed by imaging;
• Known hypersensitivity to the investigational drug or any of its excipients;
• Presence of any serious or uncontrolled systemic disease;
• History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
• Clinically significant acute or chronic pancreatitis;
• Participation in any interventional clinical trial involving drugs or medical devices within 4 weeks prior to the first administration of study treatment;
• Vaccination with live or live-attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
• Any other condition that, in the judgment of the investigator, makes the subject unsuitable for enrollment.

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-06