Study on New Immunotherapy with Anti-Angiogenesis and Chemotherapy for Advanced Gastroesophageal Cancer

Sponsor: Harry H Yoon

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04069273

This clinical trial is exploring a new treatment approach for advanced gastroesophageal cancer, combining immunotherapy, anti-angiogenesis, and chemotherapy. The study aims to determine the effectiveness and safety of this combination in controlling the disease.

Patient Parameters

Program Overview

The study is testing a new treatment for advanced gastroesophageal cancer that involves two main parts. In the first part, patients receive an immunotherapy drug called pembrolizumab every three weeks. In the second part, patients receive a combination of pembrolizumab, ramucirumab, and paclitaxel. For those who have reactions to paclitaxel, a similar drug called nab-paclitaxel may be used instead. The study is divided into two groups: one group has already closed, and the other group is currently enrolling patients who will be randomly assigned to one of two treatment arms.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide written consent.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must provide a tumor tissue sample from a biopsy, either done before joining the study or before starting treatment.
  • Must be willing to provide tissue and blood samples for research purposes.
  • Must have a type of stomach or gastroesophageal cancer that is metastatic, recurrent, or cannot be surgically removed.
  • Must be eligible for treatment with pembrolizumab, ramucirumab, and paclitaxel (or nab-paclitaxel).
  • Must have adequate organ function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after treatment ends.
  • Must be willing to return to the study site for follow-up visits.

Exclusion Criteria

  • History of lung disease or conditions that required steroid treatment.
  • Heart problems, such as abnormal heart rhythms or recent heart attacks.
  • Uncontrolled high blood pressure.
  • Recent severe gastrointestinal bleeding.
  • Liver disease or conditions causing fluid buildup in the abdomen.
  • Recent coughing up of blood or evidence of major blood vessel involvement by cancer.
  • Recent serious wounds or surgeries.
  • Active autoimmune diseases requiring treatment in the past 6 months.
  • Participation in another clinical trial within 4 weeks of starting this study.
  • Known HIV or active hepatitis B or C infections.
  • Severe allergic reactions to similar medications.
  • Active central nervous system metastases unless stable and not requiring steroids.
  • Uncontrolled illnesses or infections.
  • Pregnant or breastfeeding women.
  • Recent live vaccinations.
  • Previous severe side effects from similar treatments.
  • Previous organ transplants.

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