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Esophageal cancer trial mixes chemo, radiation, and immunotherapy

NCT ID NCT06401447

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests whether adding an immunotherapy drug (sintilimab) and immune-supporting agents to a medium-dose chemo-radiation regimen can improve outcomes for people with advanced esophageal cancer. About 50 participants will receive the combination, along with probiotics and thymosin alpha-1. The study focuses on how long the cancer stays under control and overall survival.

What this could mean

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

Active substance
paclitaxel, cisplatin, 5-FU, sintilimab, probiotics (Clostridium Butyricum), thymosin alpha-1
What this could lead to
If successful, this combination could improve how well chemoradiotherapy works for advanced esophageal cancer, potentially extending how long patients live without the cancer growing.
What could go wrong
This is a small, early-phase study with only 50 participants and no comparison group. The added drugs may increase side effects, and the benefits seen may not hold up in larger trials.

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 50 people

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

Started

Dec 2023

Expected to finish

Jul 2027

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 80 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: 1. Sign written informed consent before implementing any trial related procedures; 2. Age range from 18 to 80 years old; 3. Stage II-III and stage IV esophageal squamous cell carcinoma with only extraregional lymph node metastasis determined by histopathology; 4. Inability to undergo surgical resection or patient refusal to undergo surgery; 5. ECOG PS 0-1; 6. Expected survival time\>3 months; 7. Sufficient organ function is required for the subject to meet laboratory indicators Exclusion Criteria: 1. After esophageal or tracheal stent implantation surgery; 2. Due to the obvious invasion of tumors into adjacent organs (arteries or trachea) of the esophageal lesion, there is a higher risk of Patients at risk of bleeding or perforation, or those who have formed fistulas; 3. Diagnosed as malignant diseases other than esophageal cancer within 3 years prior to initial administration (excluding those that have undergone curative treatment) 4. Currently participating in intervention clinical research treatment, or having received other treatments within 4 weeks prior to initial administration Researching drugs or using research instruments for treatment; 5. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or targeting another stimulus or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137) Medications;

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma

As listed by the trial registrant

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

Esophageal squamous cell carcinoma

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, China

More trials for these conditions

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