CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 116 target
Drug / intervention
Paclitaxel +3 moredrug
Likely dose
Not stated in record
Key inclusion· 24
  • Age ≥18 years
  • Histologically or cytologically confirmed adenocarcinoma of stomach or gastroesophageal junction
  • Locally advanced unresectable or metastatic disease progressed ≤180 days since last treatment
  • One or more measurable or nonmeasurable evaluable lesions per RECIST
Key exclusion· 21
  • Pregnant women
  • Nursing women
  • Women of childbearing potential unwilling to use adequate contraception
  • Co-morbid systemic illnesses or severe concurrent disease interfering with safety/toxicity assessment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04660760
NCT04660760Phase 2RecruitingUpdate OverdueUpdated 27mo ago · Completion was 23mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

Ramucirumab Plus Trifluridine/Tipiracil (TAS-102) for Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: An Investigator-Initiated, Randomized Non-Inferiority Phase 2 Study

Academic and Community Cancer Research United·interventional·Posted Dec 9, 2020·Updated Apr 1, 2024

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Quality-of-Life Assessment, and 2 other interventions for Clinical Stage III Gastric Cancer AJCC v8 and 30 related conditions. Currently recruiting, targeting 116 participants across 15 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Unresectable Gastric Adenocarcinoma, Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Pathologic Stage III Gastric Cancer AJCC v8, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIA Gastric Cancer AJCC v8, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIB Gastric Cancer AJCC v8, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIC Gastric Cancer AJCC v8, Pathologic Stage IV Gastric Cancer AJCC v8, Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8, Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8, Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
CountriesUnited States

Timeline

Phase 2RecruitingOverdue
202120222023202420252026
First PostedDec 9, 2020
Enrollment StartJun 16, 2021
Primary CompletionJul 31, 2024
Study CompletionMay 31, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.6 years ago

Interventions

Paclitaxeldrug

Given IV

Quality-of-Life Assessmentother

Complete questionnaires

Ramucirumabbiological

Given IV

Trifluridine and Tipiracil Hydrochloridedrug

Given PO