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CHEMO-FREE HOPE: new trial tests skipping Post-Surgery drugs for colorectal cancer

NCT ID NCT03748485

Disease control Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is looking at whether people with locally advanced colorectal cancer who have already received chemotherapy or radiation before surgery can safely skip additional chemotherapy afterward. The trial will compare a 'wait and watch' approach to standard adjuvant chemotherapy in 650 participants whose cancer has been down-staged to stage II after pre-surgery treatment. The goal is to see if avoiding extra chemo can maintain similar outcomes while reducing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adjuvant chemotherapy (mFOLFOX6)
What this could lead to
If successful, this could show that some patients with locally advanced colorectal cancer can safely avoid additional chemotherapy after pre-surgery treatment, reducing side effects.
What could go wrong
This is an early-stage trial with no phase designation, and the benefit of skipping chemo is uncertain. The results may not apply to all patients, and there is a risk of cancer recurrence without chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 650 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * preoperative clinical tumor stage III （TxN1-2M0）CRC * pathological proved CRC adenocarcinoma by endoscopic biopsy * Post operational pathological T0-3N0M0 without high risk factors of recurrence * Patient able to understand and sign written informed consent Exclusion Criteria: * Other malignant tumors history. * Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses). * Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately. * Non resectable lymph node metastasis. * American Society of Anesthesiologists (ASA) grading≥ IV and/or, Eastern Cooperative Oncology Group(ECOG) score≥ 2. * Physical or psychological dependence. * Pregnant or breast feeding women. * Not controlled pre-operational infection. * Enrolled in other clinical trials within 4 weeks. * Other clinical or laboratorial condition not recommended by investigators.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adjuvant chemotherapy Colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sixth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

More trials for these conditions

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