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NCT04660760 · ClinicalTrials.gov registry record · Phase 2

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

A Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8, sponsored by Academic and Community Cancer Research United.

Recruiting
Registry status
Phase 2
Development phase
116
Enrollment target
15
Study locations

NCT04660760: Recruiting Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8, sponsored by Academic and Community Cancer Research United.

NCT04660760 is a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8 that is actively recruiting participants, run by Academic and Community Cancer Research United. The registered enrollment target is 116 participants, above the 92-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (26% higher). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04660760, a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8, is actively recruiting participants, sponsored by Academic and Community Cancer Research United.

RECRUITING
Registry status
Phase 2
Development phase
116 participants
Enrollment target
15
Study locations

Study 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.

Primary Outcome

Progression free survival is defined as the time interval between randomization date and the date of disease progression or death (referred to as an "event"), whichever occurs first. Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The median progression free survival will be estimated using the Kaplan-Meier method for each arm, corresponding 95% confidence intervals, and hazard ratio comparing the treatment arm to the control ar

Conditions Studied

Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastric Cancer AJCC v8 Clinical Stage III 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

Interventions

  • OTHER Quality-of-Life Assessment
  • DRUG Paclitaxel
  • BIOLOGICAL Ramucirumab
  • DRUG Trifluridine and Tipiracil Hydrochloride

Study Locations (15)

Arizona

  • Mayo Clinic in Arizona - Scottsdale
  • Arizona Clinical Research Center - Tucson

Florida

  • Mayo Clinic in Florida - Jacksonville
  • Cleveland Clinic-Weston - Weston

Wisconsin

  • Saint Vincent Hospital Cancer Center Green Bay - Green Bay
  • Aurora Cancer Care-Milwaukee West - Wauwatosa

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

California

  • USC / Norris Comprehensive Cancer Center - Los Angeles

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Illinois

  • Carle Cancer Center NCI Community Oncology Research Program - Urbana

Iowa

  • University of Iowa/Holden Comprehensive Cancer Center - Iowa City

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2021-06-16
Est. Completion 2026-05-31
Phase Phase 2
Academic and Community Cancer Research United

42 total trials

What NCT04660760 shows while recruiting

NCT04660760 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (26% higher).

The record links to 10 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.

NCT04660760 lists 15 locations in 12 states (Arizona, Florida, Wisconsin).

Frequently Asked Questions

What is clinical trial NCT04660760 about?

NCT04660760 is a clinical study titled "Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer". 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 tar...

What is the current status of trial NCT04660760?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2021-06-16. Estimated completion is 2026-05-31.

What conditions does trial NCT04660760 study?

This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8.

What interventions are being tested in trial NCT04660760?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Paclitaxel (DRUG), Ramucirumab (BIOLOGICAL), Trifluridine and Tipiracil Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT04660760?

This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04660760 being conducted?

This trial has 15 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04660760's enrollment target sits among peer trials

116 6th of 19 higher than 14 of 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04660760

Source: ClinicalTrials.gov NCT04660760, the US trial registry maintained by the National Library of Medicine. NCT04660760 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.