Efficacy and Safety Trial of XH001 (Neoantigen Cancer Vaccine) Sequential Combination With Immunocheckpoint Inhibitor and Chemotherapy in Adjuvant Therapy for Patients With Resected Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with immunocheckpoint inhibitor and chemotherapy in pancreatic cancer patients following surgical resection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form;

• Aged 18 to 75 years old;

• Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;

• Completed an R0 or R1 surgical resection as determined by pathology;

• Have not received any prior neoadjuvant therapy;

• ECOG score is 0 or 1;

• Life expectancy of greater than 12 months;

• CA19-9 \<100U/mL before initial chemotherapy;

• Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.

• Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Wenming WU, Prof.
caodingyan@pumch.cn
86-10-69156874
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Experimental: Arm A
XH001;Ipilimumab Injection;Chemotherapy
Experimental: Arm B
XH001;Sintilimab Injection;Chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Wu Wenming
Collaborators: NeoCura

This content was sourced from clinicaltrials.gov