Phase II Study on Using Immune Therapy to Preserve Organs in Colorectal or Gastroesophageal Cancer Patients

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06410534

Provider View

This study is exploring whether using immune therapy drugs, nivolumab and possibly ipilimumab, can help patients with colorectal or gastroesophageal cancer avoid or delay major surgery. The goal is to see if these drugs can effectively control the cancer and improve quality of life.

Patient Parameters

Program Overview

This study is investigating if immune therapy drugs, nivolumab and ipilimumab, can help patients with colorectal or gastroesophageal cancer avoid or delay surgery. These surgeries often affect quality of life, so researchers want to see if these drugs can control the cancer effectively. Participants will visit the clinic about 15 times over two years, with each visit lasting 4 to 8 hours. They will receive the drugs through an IV every three weeks for up to 24 weeks. If the cancer responds well, surgery may be avoided. Follow-up visits will continue every six months for up to five years.

Description

This study is testing whether immune therapy drugs, nivolumab and ipilimumab, can help patients with colorectal or gastroesophageal cancer avoid surgery. These drugs work by helping the immune system attack cancer cells. The study is for adults aged 18 and older with specific types of colorectal or gastroesophageal cancer. Participants will receive the drugs through an IV every three weeks for up to 24 weeks. They will have regular check-ups to see how the cancer is responding. If the cancer shrinks significantly, surgery might not be needed. After treatment, participants will have follow-up visits every six months for up to five years to monitor their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with stage I-III colorectal or gastroesophageal cancer.
  • Must have specific genetic markers related to the cancer.
  • Must have had a biopsy confirming the cancer stage.
  • Must have good overall health and organ function.
  • Must not have any allergies to the study drugs.
  • Must not have any major medical conditions that would interfere with the study.
  • Must not have any autoimmune or infectious conditions that would prevent immune therapy.
  • Women must not be pregnant and must agree to use contraception during the study.
  • Must be able to understand and sign a consent form.
  • Must have reasons that make surgery an unacceptable option, such as personal beliefs or previous surgeries that affect quality of life.

Exclusion Criteria

  • Currently taking other experimental drugs.
  • Previously treated with similar immune therapy drugs for the same cancer.
  • Allergic to the study drugs or similar medications.
  • Taking medications that could interfere with the study drugs.
  • Have major medical conditions that prevent surgery.
  • Have immune disorders that prevent immune therapy.
  • Have active infections.
  • Have tumors causing bowel obstruction, unless a diverting ostomy is in place.
  • Have had significant autoimmune reactions to similar drugs in the past.
  • Unable to undergo major surgery due to health reasons.
  • Have tumors that cannot be evaluated with an endoscope.
  • Have uncontrolled illnesses that would affect participation in the study.

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