Not yet recruiting NCT07691593
Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-4642+NALIRIFOX, HRS-4642+NALIRIFOX+Adebrelimab, HRS-4642+NALIRIFOX+Adebrelimab.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Exploratory Clinical Study of HRS-4642 in Combination With Chemotherapy With or Without Adebrelimab as Neoadjuvant Therapy for Pancreatic Cancer
Overview
To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.
Interventions
- Drug HRS-4642+NALIRIFOX
HRS-4642+NALIRIFOX - Drug HRS-4642+NALIRIFOX+Adebrelimab
HRS-4642+NALIRIFOX+Adebrelimab - Drug HRS-4642+NALIRIFOX+Adebrelimab
HRS-4642+NALIRIFOX+Adebrelimab
Primary outcome measures
- 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]
- 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 outcome measures (3)
- Pathologic Complete Response Rate (pCR) [Time frame: At the time of surgery]
- R0 (microscopically margin-negative) resection rate [Time frame: At the time of surgery]
- Major Pathologic Response Rate (MPR) [Time frame: At the time of surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07691593 · PANC-HRS4642-SHR1316-NALIRIFOX