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NCT04920032 · ClinicalTrials.gov registry record · Phase 1

Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas

A Phase 1 study of Colorectal Cancer and Colon Adenocarcinoma, sponsored by University of California, Irvine.

Recruiting
Registry status
Phase 1
Development phase
22
Enrollment target
1
Study location

NCT04920032: Recruiting Phase 1 study of Colorectal Cancer and Colon Adenocarcinoma, sponsored by University of California, Irvine.

NCT04920032 is a Phase 1 study of Colorectal Cancer and Colon Adenocarcinoma that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 22 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04920032, a Phase 1 study of Colorectal Cancer and Colon Adenocarcinoma, is actively recruiting participants, sponsored by University of California, Irvine.

RECRUITING
Registry status
Phase 1
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

Primary Outcome

Percent of patients positive for ctDNA after 6 cycles or at least 3 months months after starting adjuvant treatment will be used to estimate the efficacy of adjuvant trifluridine and tipiracil (TAS102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma. The Signatera MRD ctDNA Assay will be used to measure ctDNA positivity.

Interventions

  • DRUG Irinotecan
  • DRUG TAS-102
  • COMBINATION_PRODUCT Standard Treatment
  • DIAGNOSTIC_TEST Signatera MRD ctDNA Assay

Study Locations (1)

California

  • Chao Family Comprehensive Cancer Center, University of California, Irvine - Orange

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2021-08-26
Est. Completion 2026-12-31
Phase Phase 1
University of California, Irvine

368 total trials

What NCT04920032 shows while recruiting

NCT04920032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Irinotecan is the first listed.

NCT04920032 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04920032 about?

NCT04920032 is a clinical study titled "Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas". This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

What is the current status of trial NCT04920032?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-08-26. Estimated completion is 2026-12-31.

What conditions does trial NCT04920032 study?

This clinical trial studies the following conditions: Colorectal Cancer, Colon Adenocarcinoma.

What interventions are being tested in trial NCT04920032?

The interventions under investigation include: Irinotecan (DRUG), TAS-102 (DRUG), Standard Treatment (COMBINATION_PRODUCT), Signatera MRD ctDNA Assay (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04920032?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04920032 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Colorectal Cancer

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 NCT04920032's enrollment target sits among peer trials

22 341st of 381 higher than 38 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer 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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Source: ClinicalTrials.gov NCT04920032, the US trial registry maintained by the National Library of Medicine. NCT04920032 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.