Phase 2 Oesophageal Cancer Trial, Recruiting NCT07385001 Sponsor: Tang-Du Hospital Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT07385001
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have given written consent before any study procedures begin.
  • People aged between 18 and 75 years old (inclusive), of any gender.
  • People who have been confirmed through a tissue sample (biopsy) to have a specific type of esophageal (food pipe) cancer called squamous cell carcinoma, at a locally advanced but operable stage, meeting specific staging criteria as defined by the trial.
  • People whose neck lymph nodes show no suspicious signs on ultrasound or CT scan, and whose scans show no sign of cancer spreading to other parts of the body.
  • People whose cancer is expected to be fully removable by surgery with no cancer left behind (known as R0 resection).
  • People who have at least one measurable tumor visible on imaging.
  • People with a good general health and activity level, rated 0 or 1 on a standard medical scale (ECOG), meaning they are fully active or have only minor limitations in physical activity.
  • People expected to live for at least 3 months.
  • People with normal thyroid hormone levels, or whose thyroid-stimulating hormone is slightly outside the normal range but whose other thyroid hormones are normal.
  • People whose blood, liver, kidney, and clotting test results meet the specific levels required by the trial, without having received blood transfusions or certain blood-boosting treatments in the 14 days beforehand.
  • People whose heart is pumping at a sufficient level, with a heart function score (left ventricular ejection fraction) of 50% or above.
  • Women of childbearing age who have a negative pregnancy test at the screening stage.
  • People of reproductive capacity who are willing to use reliable contraception from the time of signing consent until 90 days after the last dose of the study drug.
  • People who are willing and able to follow the trial schedule, including all visits, treatments, and tests.

Who may not be able to join:

  • People who have had another type of cancer within the past 5 years, unless it was a very localised or non-invasive cancer (such as certain skin cancers, early bladder cancer, or early-stage cervical or breast changes) that was treatable with local therapy only.
  • People who have previously been treated with certain immune checkpoint drugs (such as PD-1 or PD-L1 inhibitors), other immune-targeting drugs (such as CTLA-4 or OX-40 treatments), or anti-blood vessel growth drugs (such as bevacizumab or endostar).
  • People who have received certain immune-boosting therapies (such as interleukins, interferons, or thymopentin), or certain traditional herbal medicines with anti-cancer indications, within 2 weeks before the first study dose.
  • People who have an active autoimmune disease (where the immune system attacks the body) that currently requires systemic treatment such as immune-suppressing drugs or steroids — though hormone replacement therapies for conditions like an underactive thyroid or adrenal insufficiency are not considered disqualifying.
  • People who have cancer that has spread to the brainstem, the lining of the brain, or the spinal cord, or who have signs of pressure or compression in those areas.
  • People who have significant fluid build-up around the lungs, heart, or abdomen that requires ongoing medication or repeated draining.
  • People who have had a serious bowel blockage, a hole in the gut, an abscess in the abdomen, or an abnormal passage (fistula) in the digestive tract within 6 months before the first dose.
  • People who have active inflammatory bowel conditions such as Crohn's disease, ulcerative colitis, radiation-related gut damage, bleeding bowel disease, or ongoing diarrhoea.
  • People whose scans show the tumour is wrapped around major blood vessels, or show significant tissue death or cavities in the tumour, where the trial doctors consider there to be a bleeding risk.
  • People who have moderate or severe scarring or inflammation of the lung tissue (interstitial lung disease, Grade 2 or higher).
  • People with serious heart or blood vessel conditions, including: uncontrolled high blood pressure or high blood pressure in the lungs; unstable chest pain, a heart attack, heart bypass surgery, or a stent fitted within the past 6 months; significant heart failure; a heart pumping function below 50%; certain serious irregular heart rhythms; or a stroke or mini-stroke (TIA) within the past 4 weeks.
  • People who have had a serious infection (such as blood poisoning or severe pneumonia) within 4 weeks before the first dose, or who have been on systemic antibiotics or antimicrobial treatment for an active infection within 2 weeks before the first dose (antiviral treatment for hepatitis B or C is not considered disqualifying).
  • People with known active tuberculosis (TB) or active syphilis — suspected TB cases must be medically assessed and ruled out before joining.
  • People who test positive for HIV antibodies, or who have active hepatitis B or hepatitis C infection (confirm with trial site for full details on this criterion).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 15991269383

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Tang-Du Hospital
Registry
ClinicalTrials.gov
Start date
28 January 2026
Est. completion
28 January 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

DLT; Incidence and Severity of Adverse Events; MTD; RP2D; Major Pathologic Response(MPR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov