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An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age: ≥18 years old, male or female;

• Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;

• Arm 1 included patients with locally advanced or metastatic pancreatic cancer whose imaging assessment met the guideline definition, and Arm 2 included patients with borderline resectable pancreatic cancer whose imaging assessment met the guideline definition;

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

• Expected survival ≥ 6 months;

• Adequate marrow and organ function;

• Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration;

• Patients volunteered to participate in this study and signed informed consent.

Locations
Other Locations
China
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Wenquan Wang, Ph.D.
wang.wenquan@zs-hospital.sh.cn
13701874954
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 60
Treatments
Experimental: Arm1:locally advanced/metastatic pancreatic cancer
HRS-4642 in Combination with Immunotherapy and Chemotherapy
Experimental: Arm 2: borderline resectable pancreatic cancer
HRS-4642 in Combination with Immunotherapy and Chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov