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Can a Three-Drug cocktail shrink stomach tumors before surgery?

NCT ID NCT06447636

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether adding surufatinib (a targeted therapy that blocks blood vessel growth) to standard immunotherapy and chemotherapy can improve outcomes for people with locally advanced stomach or gastroesophageal junction cancer. The treatment is given before and after surgery to shrink the tumor and increase the chance of complete removal. The study will measure how many patients have no cancer cells left in the removed tissue (pathological complete response) and how long they remain cancer-free.

What this could mean

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

Active substance
a combination of surufatinib (a kinase inhibitor), sintilimab (an immunotherapy), and chemotherapy (oxaliplatin and S1)
What this could lead to
If successful, this approach could improve tumor shrinkage before surgery and increase the chance of complete removal, potentially leading to better long-term survival for people with locally advanced gastric cancer.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply broadly. The combination of drugs may cause significant side effects, and it is not yet known whether it will improve outcomes compared to standard treatment.

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.

Started

Sep 2024

Expected to finish

May 2029

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: * signed informed consent * patients age 18-75 years; * Histologically CT/MRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma; * ECOG 0-1, no surgery contraindications; * Expected survival ≥3 months; Exclusion Criteria: * signs of distant metastases * Prior chemotherapy, radiotherapy, surgery for gastric cancer; * Significant cardiovascular disease * major surgical procedure within 4 weeks prior to initiation of study treatment * current treatment with anti-viral therapy or HBV * pregnancy or breastfeeding * history of malignancy within 5 years prior to screening * Present or history of any autoimmune disease or immune deficiency; * Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent; * There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors. * Poorly controlled hypertension or diabetes;

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Gastric cancer Gastro esophageal junction cancer

Contacts and locations

Locations

  • Fudan University Cancer Hospital

    Shanghai, China

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