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New combo therapy for Hard-to-Treat gut tumors enters final testing phase

NCT ID NCT07185672

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding chemotherapy (capecitabine and temozolomide) to standard radiation therapy (PRRT) helps people with advanced neuroendocrine tumors of the stomach, pancreas, or intestines that show high activity on FDG PET scans. The study plans to enroll 162 adults whose tumors are well-differentiated but FDG-avid, meaning they are more aggressive. Participants will be randomly assigned to receive PRRT alone or PRRT plus chemotherapy, and researchers will compare how long they live without the cancer growing.

What this could mean

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

Active substance
Lutetium-177 PRRT (radiation therapy) plus capecitabine and temozolomide (chemotherapy)
What this could lead to
If successful, this combination could improve progression-free survival for people with aggressive neuroendocrine tumors that are not controlled by standard PRRT alone.
What could go wrong
This is a Phase 3 trial, but it is still recruiting and results are not yet available. Adding chemotherapy may increase side effects without guaranteeing better outcomes.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 162 people

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

Started

Aug 2019

Expected to finish

Aug 2027

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 years and older

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 GEP-NET, necessarily satisfying all the the criteria below * Well differentiated G2 (Ki67 : ≥3-20%) OR G3 (ki67- greater than 20-55%), OR * Well-differentiated G1 (\<3%) with disease progression in last 6 months * Positive Ga-68-DOTANOC PET/CT, Krennings score \>/=3 * Positive FDG PET imaging, grade 3 or 4 uptake * Locally advanced/inoperable disease or metastatic disease * 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 noty 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 * Treatment with more than 30 mg of octreotide LAR within 4 weeks before randomisation. * Peptide receptor radionuclide therapy at any time before randomisation * Pregnancy and Lactation * Patients with concurrent malignancies

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Neuroendocrine gastroenteropancreatic tumour Neuroendocrine neoplasia's (NENS) Neuroendocrine tumor gep grade 1-3

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

Other studies related to the condition(s) this trial covers.