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New radiation therapy shows promise for Hard-to-Treat gut cancers

NCT ID NCT07404176

Disease control Sponsor: Tata Memorial Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a new radioactive drug called Terbium-161 DOTATATE in 20 people with advanced neuroendocrine tumors that have spread and stopped responding to standard treatment. The drug delivers radiation directly to cancer cells, aiming to control the disease with fewer side effects. Researchers will measure how well it shrinks or stabilizes tumors and monitor safety through blood tests and scans.

What this could mean

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

Active substance
Terbium-161 DOTATATE (a radioactive drug that targets cancer cells)
What this could lead to
If successful, this could offer a new treatment option for patients with neuroendocrine tumors that no longer respond to current therapies, potentially with fewer side effects.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The drug is experimental, and its safety and effectiveness are not yet proven.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 70 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: * Male or female, age greater than 18 years * Histopathological diagnosis of well-differentiated GEP-NET * Positive Ga-68-DOTANOC PET/CT, Krennings score \>/=3 * Locally advanced/inoperable disease or metastatic disease * Patient who have shown disease progression with Lu-177 DOTATATE PRRT * Karnofsky performance-status score of at least 60 or ECOG performance status \</=2 * Life expectancy greater than 6 months Exclusion Criteria: * Serum creatinine level of more than 1.6 mg/dl or a creatinine clearance of less than 50 ml/min * Hemoglobin level of less than 8.0 g per deciliter * Red blood cell count less than 300,000/cubic millimeter * White cell count of less than 2000 per cubic millimeter * Platelet count of less than 75,000 per cubic millimetre * Total bilirubin level of more than 3 times the upper limit of the normal range * Serum albumin level \> 3.0 g/dl * Pregnancy and Lactation * Patients with concurrent malignancies

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine tumor, grade 1/2 neoplasm neuroendocrine neoplasm

As listed by the trial registrant

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

Metastatic neuroendocrine tumors Neuroendocrine neoplasms (tumours) Neuroendocrine tumors

How to take part

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

  1. The places running it

    2 sites. 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

  • Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

    RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

  • Tata Memorial Hospital, Mumbai, India

    RECRUITING

    Mumbai, Maharashtra, 400012, India

More trials for these conditions

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