Phase 1 Oesophageal Cancer Trial, Recruiting NCT07317609 Sponsor: Shanghai Zhongshan Hospital Condition: Oesophageal Cancer
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Phase 1 Oesophageal Cancer Trial, Recruiting

NCT07317609
Recruiting Phase 1

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:

This trial has two groups (Cohort A and Cohort B). Please check which group may apply.

Cohort A – Esophageal cancer that may be removable by surgery:

  • People between 18 and 80 years old.
  • People who have been diagnosed with a specific type of esophageal cancer called squamous cell carcinoma, confirmed by a tissue biopsy.
  • People whose cancer has been assessed by scans and endoscopy as potentially removable by surgery, with the tumor at a certain stage, no larger than 5 cm, and not blocking more than two-thirds of the food pipe.
  • People who have not previously received any cancer treatment, including surgery, radiation, chemotherapy, immunotherapy, or targeted therapy.
  • People whose general physical functioning has been rated at a good to moderate level using a standard medical scoring system called the ECOG scale (score of 0 or 1) (confirm with trial site).
  • People whose overall fitness for anaesthesia has been assessed as acceptable using a standard classification system (confirm with trial site).
  • Women of childbearing age who have a negative pregnancy test and are willing to use effective contraception throughout the study.
  • People who have given their written agreement to participate.

Cohort B – Esophageal cancer where surgery is not suitable:

  • People aged 18 or older.
  • People who have been diagnosed with esophageal squamous cell carcinoma, confirmed by a tissue biopsy.
  • People whose cancer cannot be treated with surgery — this may include people with cancer in the upper part of the food pipe (near the throat), people who have a medical reason preventing surgery, people who have chosen not to have surgery, or people considered high-risk for surgery due to at least one of the following: being over 75 years old, having significant other health conditions, having moderate lung problems, or being significantly underweight (body mass index below 18 kg/m²).
  • People whose cancer is at a certain stage, with a tumor no larger than 5 cm and not blocking more than two-thirds of the food pipe.
  • People who have not previously received any cancer treatment, including surgery, radiation, chemotherapy, immunotherapy, or targeted therapy.
  • Women of childbearing age who have a negative pregnancy test and are willing to use effective contraception throughout the study.
  • People who have given their written agreement to participate.

Who may not be able to join:

Cohort A exclusions:

  • People who have, or are suspected to have, an abnormal connection between the food pipe and the airway or major blood vessels.
  • People with severe malnutrition or who need tube feeding.
  • People who have had another type of cancer in the past two years that has not been fully treated (exceptions may apply for certain skin and cervical cancers — confirm with trial site).
  • People who have an active autoimmune disease, a history of autoimmune disease, or symptoms that require treatment with steroid or immune-suppressing medications.
  • People with a weakened immune system, or people who have been taking steroid medications above a certain dose or other immune-suppressing treatments within seven days before starting the study treatment.
  • People who have had an active infection requiring medication within seven days before starting the study treatment.
  • People who have previously received an organ or stem cell transplant from another person.
  • People who have a known allergy to any of the medications or ingredients used in this study.
  • People who are currently taking part in another clinical trial.

Cohort B exclusions:

  • People who have a known allergy to any of the medications or ingredients used in this study.
  • People who are currently taking part in another clinical trial.

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 27 July 2026
Phase 1: approximately ~10% 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 13162909612

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 1
Registry
ClinicalTrials.gov
Start date
15 July 2025
Est. completion
30 September 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Organ preservation rate; Overall safety: incidence of Grade ≥3 adverse events related to drug, endoscopic procedures, surgery, or radiation; Two-year overall survival rate; Biomarkers

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: 27 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