New combo therapy may let some esophageal cancer patients skip major surgery
NCT ID NCT07317609
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shanghai Zhongshan Hospital
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why does esophageal cancer come back after treatment? researchers search medical records for clues
- Which Pre-Surgery combo extends life in esophageal cancer? a virtual trial seeks answers
- Can an AI eye guide surgeons to safer, faster cancer removal?
- Can a triple punch of immunotherapy and chemoradiation wipe out esophageal tumors before surgery?
- Can early tumor response guide smarter cancer treatment?
- Could a smart combo of drugs and radiation help some esophageal cancer patients skip surgery?