Study on Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for Treating Advanced Stomach or Gastroesophageal Junction Cancer

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04660760

Provider View

This clinical trial is testing a combination of treatments for patients with advanced stomach or gastroesophageal junction cancer that has spread and been previously treated. The study aims to see if the combination of ramucirumab with either trifluridine/tipiracil or paclitaxel can effectively control the cancer.

Patient Parameters

Program Overview

This study is exploring whether a combination of treatments can help control advanced stomach or gastroesophageal junction cancer that has spread to other parts of the body. The treatments being tested include ramucirumab, which targets blood vessels that feed tumors, and either trifluridine/tipiracil, a chemotherapy pill that damages cancer cell DNA, or paclitaxel, which stops cancer cells from dividing. The goal is to see if these combinations are as effective as current treatments in managing the cancer.

Description

The main goal of this study is to compare how long patients with advanced stomach or gastroesophageal junction cancer can live without their disease getting worse when treated with ramucirumab combined with either trifluridine/tipiracil or paclitaxel. Researchers will also look at overall survival rates and changes in quality of life for patients receiving these treatments.

Participants will be randomly assigned to one of two groups:

  • Group A: Will receive trifluridine/tipiracil pills twice daily on specific days, along with ramucirumab given through an IV on certain days. This cycle repeats every 28 days for up to 36 cycles unless the cancer progresses or side effects become too severe.

  • Group B: Will receive paclitaxel through an IV on specific days, along with ramucirumab given through an IV on certain days. This cycle also repeats every 28 days for up to 36 cycles unless the cancer progresses or side effects become too severe.

After finishing the treatment, patients will have follow-up visits initially 30-35 days after treatment, then every three months for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of stomach or gastroesophageal junction cancer.
  • Cancer must have spread or be inoperable and have worsened within 180 days of the last treatment.
  • Have at least one tumor that can be measured.
  • Must have tried and not responded to previous standard chemotherapy treatments.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be able to swallow pills.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Be willing to complete questionnaires and return for follow-up visits.
  • Provide written informed consent to participate in the study.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have serious health conditions that could interfere with the study.
  • Have previously been treated with TAS-102 or ramucirumab.
  • Have had recent severe gastrointestinal bleeding or blood clots.
  • Have had recent major surgery or plan to have major surgery during the study.
  • Have uncontrolled high blood pressure or significant liver disease.
  • Have an active infection or other serious illness that could affect participation.
  • Be taking other investigational drugs or treatments for cancer.
  • Have another active cancer within the last three years, except for certain skin or cervical cancers.
  • Be on chronic antiplatelet therapy, except for low-dose aspirin.

Get This Program In Your Inbox

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