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NCT Number: NCT07691593

Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

HRS-4642+NALIRIFOX

Drug

HRS-4642+NALIRIFOX

HRS-4642+NALIRIFOX+Adebrelimab

Drug

HRS-4642+NALIRIFOX+Adebrelimab

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Pathologic Complete Response Rate (pCR)

    Time frame: At the time of surgery

  2. R0 (microscopically margin-negative) resection rate

    Time frame: At the time of surgery

  3. Major Pathologic Response Rate (MPR)

    Time frame: At the time of surgery

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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