RecruitingNot ApplicableNCT06353646

XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer

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


Sponsor

Wu Wenming

Enrollment

28 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination treatment after surgery for pancreatic cancer. Patients who have had their tumor removed will receive a drug called XH001 alongside an immunotherapy drug and chemotherapy to help prevent the cancer from coming back. **You may be eligible if...** - You are 18–75 years old with a confirmed diagnosis of pancreatic cancer (adenocarcinoma) - You have had a complete or near-complete surgical removal of your tumor (R0 or R1 resection) - You have not received any chemotherapy or other cancer treatment before surgery (no neoadjuvant therapy) - Your cancer marker (CA19-9) was below 100 U/mL before starting treatment - You are in good general health (ECOG score 0 or 1) with an expected survival of more than 12 months **You may NOT be eligible if...** - Your cancer has come back or spread after surgery - You have fluid build-up in the abdomen caused by cancer - You have inflammatory bowel disease, bowel blockage, or severe diarrhea after surgery - You have had a recent stroke, heart attack, or severe heart failure - You have a history of autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALXH001

XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)

DRUGIpilimumab Injection

Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)

DRUGSintilimab injection

Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)

DRUGChemotherapy

gemcitabine + capecitabine


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06353646


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