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Clinical Trial Summary

This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine whether radiation therapy can convert overall response rates from progressive disease to stable or responsive disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1. SECONDARY OBJECTIVES: I. To define overall response rate by immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria. II. To determine time to progression. III. To determine overall survival. IV. To determine local control in radiated lesion(s). V. To characterize the effect of distant radiation on unirradiated target lesions. VI. To describe the incidence of new metastatic lesions. VII. To determine treatment safety by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. VIII. To describe time to new systemic therapy. EXPLORATORY OBJECTIVES: I. To define radiation-induced effects on circulating immune cells. II. To describe remodeling of the circulating T cell repertoire by deep sequencing of variable, diversity and joining (VDJ) regions of T cell receptors (TCRs). III. To describe changes in circulating tumor deoxyribonucleic acid (DNA) (ctDNA). OUTLINE: Patients undergo radiation therapy for a total of 5 treatments over 5-9 calendar days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 14 day, 6 months, and then up to 36 months. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Anus Neoplasms
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Squamous Cell
  • Colorectal Neoplasms
  • Digestive System Neoplasms
  • Esophageal Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • Gastrointestinal Neoplasms
  • Metastatic Anal Canal Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Esophageal Carcinoma
  • Metastatic Gastric Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Metastatic Hepatocellular Carcinoma
  • Metastatic Malignant Digestive System Neoplasm
  • Metastatic Small Intestinal Carcinoma
  • Pancreatobiliary Carcinoma
  • Pathologic Stage IV Gastric Cancer AJCC v8
  • Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8
  • Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Stage IV Adenocarcinoma of the Gastroesophageal Junction
  • Stage IV Anal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Esophageal Adenocarcinoma
  • Stage IV Esophageal Squamous Cell Carcinoma
  • Stage IV Gastric Cancer
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IVA Adenocarcinoma of the Gastroesophageal Junction
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVA Esophageal Adenocarcinoma
  • Stage IVA Esophageal Squamous Cell Carcinoma
  • Stage IVA Gastric Cancer
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVB Esophageal Adenocarcinoma
  • Stage IVB Esophageal Squamous Cell Carcinoma
  • Stage IVB Gastric Cancer
  • Stage IVB Gastroesophageal Junction Adenocarcinoma
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8
  • Stomach Neoplasms

NCT number NCT04221893
Study type Interventional
Source University of California, San Francisco
Contact Hewitt Chang
Phone (415) 514-1571
Email Hewitt.Chang@ucsf.edu
Status Recruiting
Phase N/A
Start date August 7, 2020
Completion date November 30, 2026

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