Phase 2 Oesophageal Cancer Trial, Recruiting NCT05173246 Sponsor: Sun Yat-sen University Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT05173246
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:

  • Adults between 18 and 75 years old (male or female)
  • People who have been diagnosed with esophageal small cell carcinoma (a specific type of oesophageal cancer) that has been confirmed by a lab test, and cannot be removed by surgery, has come back, or has spread to other parts of the body
  • People who have not yet had any systemic (whole-body) treatment for their cancer
  • People whose cancer came back or spread more than 6 months after completing chemotherapy given alongside surgery or combined chemotherapy and radiation treatment
  • People who have at least one tumour that can be measured on a scan, according to standard medical criteria (RECIST 1.1)
  • People who are generally well enough to carry out light activities — rated 0 or 1 on a standard performance scale used by doctors (ECOG score)
  • People who are expected to live for at least 3 months
  • People whose blood, liver, and kidney test results fall within the ranges required by the trial (confirm with trial site for specific values)
  • Women who could become pregnant must have a negative pregnancy test before joining and must use contraception during the trial and for 3 months after the last dose
  • People who are willing and able to read and sign a consent form
  • People who agree to provide a stored tumour tissue sample, or have a biopsy taken, for genetic testing

Who may not be able to join:

  • People with a known allergy to the study drug, its ingredients, or similar medicines
  • People who have received cancer treatments such as chemotherapy, biological therapies (including monoclonal antibodies), immunotherapy, or other experimental treatments within 4 weeks before joining
  • People who have received a type of targeted cancer medicine called a tyrosine kinase inhibitor within 2 weeks before joining
  • People who have had radiotherapy within 4 weeks, or radioactive drug treatment within 8 weeks, before joining — except for limited radiotherapy used to manage bone pain
  • People who had major surgery within 4 weeks before joining, or who have not fully recovered from a previous surgery (confirm with trial site for how "major surgery" is defined)
  • People who are still experiencing significant side effects from previous cancer treatment that have not sufficiently settled (with some specific exceptions — confirm with trial site)
  • People with active, symptomatic cancer spread to the brain or the lining of the brain — though people whose brain metastases have been treated and have been stable for at least 2 months, and who have stopped steroid treatment for more than 4 weeks, may be considered
  • People who have, or have had, another cancer in the past 5 years — with some exceptions, such as certain skin cancers or early-stage cancers that have been successfully treated (confirm with trial site)
  • People with an active autoimmune disease or a history of certain autoimmune conditions (confirm with trial site for the full list of conditions that may apply)
  • People who have previously been treated with certain immune checkpoint medicines, including anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies
  • People who currently have active tuberculosis (TB) or who have been treated for TB within the past year
  • People who require long-term use of immune-suppressing medications or steroid medicines above a certain dose
  • People who have received any live or anti-infection vaccine within 4 weeks before joining
  • Women who are pregnant or breastfeeding
  • People who test positive for HIV
  • People with certain results on hepatitis B or hepatitis C blood tests (confirm with trial site for specific thresholds)
  • People with serious heart conditions, including significant heart failure, unstable chest pain (angina), a heart attack within the past year, or certain heart rhythm problems requiring treatment
  • People with any other medical condition or situation that the trial doctors consider would make participation unsuitable

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 26 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

Principal Investigator: Rui-hua Xu, PhD, Sun Yat-sen University

Phone: +862087342635

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
Registry
ClinicalTrials.gov
Start date
17 November 2020
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective response rate (ORR)

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: 26 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