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New cocktail of drugs aims to fight tough esophageal cancer

NCT ID NCT07481058

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new oral drug called KC1036 combined with standard immunotherapy (toripalimab) and chemotherapy (paclitaxel and cisplatin) as a first treatment for advanced esophageal cancer that has spread or come back. The trial will enroll 60 adults aged 18-75 who have not had prior treatment for their advanced disease. The main goal is to see how many patients' tumors shrink or disappear, while also monitoring safety and how long the benefits last.

What this could mean

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

Active substance
KC1036 (oral drug) combined with toripalimab (immunotherapy), paclitaxel, and cisplatin (chemotherapy)
What this could lead to
If successful, this combination could offer a new first-line treatment option for advanced esophageal cancer, potentially shrinking tumors and delaying disease progression.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The combination of drugs may cause significant side effects, and there is no guarantee it will work better than existing treatments.

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 60 people

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

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Males or females aged 18 to 75 years; * Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma; * Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease; * At least one measurable tumor lesion according to RECIST 1.1; * Eastern Cooperative Oncology Group performance status score of 0 or 1; * Life expectancy \> 12 weeks; * BMI≥16.0 kg/m2; * Adequate bone marrow, renal, and hepatic function; * Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before the first dose; * Patients should participate in the study voluntarily and sign informed consent. Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis; * Other malignancies within the past 5 years; * Known hypersensitivity to any monoclonal antibodies or chemotherapy components; * Gastrointestinal abnormalities; * High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula; * Cardiovascular and cerebrovascular diseases; * Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment; * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; * Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1; * Active autoimmune disease or a history of autoimmune disease requiring systemic treatment; * Active infections, including severe infection (CTCAE \> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV; * Pregnant or lactating women; * Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study; * Other conditions assessed by the investigator that would increase safety risks or interfere with the study results.

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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.

  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

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, 100021, China

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