Study on Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Cancer

Sponsor: University of Wisconsin, Madison

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04150640

Provider View

This clinical trial is testing a new combination of chemotherapy and immunotherapy drugs to see if they are safe and effective as a first treatment for advanced esophageal and gastric cancer. The study includes an additional drug, trastuzumab, for patients with HER2-positive tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for advanced esophageal and gastric cancer using a combination of chemotherapy drugs (5-FU, oxaliplatin, and nal-IRI) and immunotherapy. For patients with HER2-positive tumors, the treatment also includes trastuzumab. The goal is to find out if this combination is safer and better tolerated than current treatments.

Description

This clinical trial is testing a new combination of drugs for treating advanced esophageal and gastric cancer. The study is divided into four groups based on the type of cancer and specific markers:

  • Cohort 1 (HER2-negative): Participants will receive 5-FU, oxaliplatin, and nal-IRI.
  • Cohort 2 (HER2-positive): Participants will receive 5-FU, oxaliplatin, nal-IRI, and trastuzumab.
  • Cohort 3 (HER2-negative): Participants will receive 5-FU, oxaliplatin, nal-IRI, and nivolumab.
  • Cohort 4 (HER2-positive): Participants will receive 5-FU, oxaliplatin, nal-IRI, trastuzumab, and pembrolizumab.

The study aims to evaluate the safety and effectiveness of these drug combinations. Participants will receive the same doses of chemotherapy, and any necessary adjustments will be made based on side effects. The study will follow standard procedures for similar treatments.

Each group will have a specific number of participants to assess the safety and tolerability of the treatments. The study will help determine if these new combinations can be a better option for patients with advanced esophageal and gastric cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must have a performance status score of 0-2, indicating good overall health.
  • Must have confirmed advanced esophageal or gastric cancer with known HER2 and PDL1 status.
  • Must have measurable cancer according to specific criteria.
  • Must not have received prior systemic therapy for advanced cancer.
  • Must have adequate organ function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be able to understand and comply with study procedures.

Exclusion Criteria

  • Allergic reactions to any of the study drugs.
  • Other active cancers requiring treatment within the last 2 years, except for certain non-threatening cancers.
  • Participation in another clinical study with investigational drugs.
  • Recent major surgery or radiation therapy.
  • Conditions that require systemic treatment with steroids or other immunosuppressive drugs.
  • Active infections or psychological conditions that may affect study participation.
  • Pregnant or breastfeeding women.
  • Active brain metastases or severe heart conditions.
  • Known HIV infection.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.