Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo therapy may let some esophageal cancer patients skip major surgery

NCT ID NCT07317609

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving chemotherapy plus immunotherapy before treatment can shrink esophageal tumors enough to remove them with an endoscope (a thin tube down the throat) instead of major surgery. About 60 adults with early-stage esophageal cancer will receive two or more cycles of the drug combination. If the tumor shrinks completely, doctors may remove it endoscopically, preserving the esophagus. The goal is to see if this approach is safe and feasible, reducing the need for esophagectomy.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Started

Jul 2025

Expected to finish

Sep 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 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.

Cohort A - Potentially resectable ESCC: Inclusion Criteria: 1. Age range: 18-80 years old; 2. Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor; 3. Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not exceeding 5 cm and occupying less than 2/3 of the luminal circumference); Patients who have not received any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy; 4. Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III; 6. Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period; 7. Patients who have signed the informed consent form. Exclusion Criteria: 1. Patients with potential tracheoesophageal fistula or aortoesophageal fistula; 2. Patients with severe malnutrition or requiring tube feeding; 3. Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix); 4. Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy; 5. Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone \> 10 mg/day or equivalent) or other forms of immunosuppressive therapy within 7 days before the first dose of neoadjuvant therapy in this study; 6. Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study; 7. Patients with a history of allogeneic organ or stem cell transplantation; 8. Patients with allergies to drugs or related components involved in this study; 9. Patients who are currently participating in any other clinical study. Cohort B - Surgery-contraindicated ESCC: Inclusion Criteria: 1. Individuals aged above 18 years; 2. Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor; 3. Patients with esophageal cancer deemed as surgically contraindicated (including those with cervical esophageal cancer, surgical contraindications, those who refuse surgery, or those considered high-risk for esophagectomy, defined as having at least one of the following characteristics: (1) age over 75 years, (2) Charlson comorbidity index \>= 2, (3) presence of moderate lung dysfunction, (4) malnutrition (with a body mass index below 18 kg/m\^2)), with a clinical staging of cT1b-3N0M0, a tumor size not exceeding 5 cm, and occupying less than 2/3 of the luminal circumference; 4. Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy; 5. Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period; 6. Patients who have signed the informed consent form. Exclusion Criteria: 1. Patients with allergies to the drugs or related components involved in this study; 2. Patients who are currently participating in any other clinical study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Esophageal squamous cell carcinoma (ESCC) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Shanghai Zhongshan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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