Phase 1 Stomach Cancer Trial, Recruiting NCT04778839 Sponsor: First Affiliated Hospital of Zhejiang University Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT04778839
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:

  • People who have been confirmed by tissue or cell testing to have advanced solid tumours, where standard cancer treatments have either stopped working or are no longer available.
  • People aged between 18 and 70 years old (male or female).
  • People who are expected to live for at least 3 months.
  • People whose general physical functioning falls within a certain range on a standard health scale (ECOG score of 0–2, meaning able to carry out at least some daily activities — confirm with trial site).
  • People who have at least one tumour that can be measured or assessed using standard imaging methods.
  • People who have not received radiotherapy, chemotherapy, immunotherapy, other anti-tumour treatments, or surgery (other than diagnostic biopsy) within the 4 weeks before joining, and who do not have surgery planned during the study period.
  • People whose blood counts (red cells, white cells, and platelets) are within acceptable levels, without having needed a blood transfusion or blood-boosting medications in the 14 days before screening.
  • People whose heart, liver, and kidney function test results fall within acceptable ranges as defined by the trial.
  • People whose blood clotting test results are within normal limits.
  • People (and their partners) who are willing to use reliable contraception during the study and for 3 months after the last dose. Women who could become pregnant must have a negative pregnancy blood test within 14 days before joining and must not be breastfeeding.
  • People who are willing to sign an informed consent form, showing they understand what the trial involves, including possible side effects.
  • People who are willing to follow the study rules and attend follow-up visits.

Who may not be able to join:

  • People who still have side effects from previous cancer treatment that have not reduced to a mild level (with some exceptions, such as hair loss).
  • People who have a known or suspected allergy to paclitaxel or any of its ingredients, or who have a history of serious allergic reactions (mild seasonal allergies without symptoms are excluded).
  • People who have a tendency to bleed, or who are currently taking blood-thinning or clot-dissolving medications.
  • People whose cancer has previously been treated with paclitaxel and was found by doctors to be resistant to it.
  • People who have active cancer that has spread to the brain or central nervous system — although people with previously treated and stable brain metastases may still be considered.
  • People who have had a stroke or a temporary stroke-like episode (TIA) in the 6 months before screening.
  • People who currently have an active infection requiring antibiotic or antiviral treatment.
  • People who have had another type of cancer in the past 5 years (with the exception of certain fully treated skin and cervical cancers).
  • People who have other serious illnesses that the doctors believe could put them at risk or prevent them from completing the trial (such as bowel obstruction, lung scarring, or gastrointestinal bleeding).
  • People with a known history of neurological or psychiatric conditions, including epilepsy or dementia.
  • People who have taken certain medications that affect how the body processes drugs (specific CYP2C8 and/or CYP3A4 interacting medicines) within 30 days before starting the trial drug — confirm the specific medications with the trial site.
  • People who have received a blood transfusion or blood products such as albumin within 2 weeks before the trial.
  • People who have moderate to severe nerve damage in their hands or feet (peripheral neuropathy above grade II).
  • People who have had a heart attack in the past 6 months, serious or unstable chest pain, certain heart bypass procedures, severe heart failure, uncontrolled high blood pressure, significant heart rhythm problems, or concerning heart test (ECG) results.
  • People who have HIV, active hepatitis B, or active hepatitis C infection (based on specific blood test results — confirm with trial site).
  • People who have consumed more than 14 standard alcoholic drinks per week in the 2 weeks before screening, or who have a history of drug abuse.
  • People who have taken part in another clinical trial within the past month.
  • People who are pregnant or breastfeeding.
  • People who the trial doctors consider unsuitable for any other reason.

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 28 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

Principal Investigator: jian liu, master, The First Affiliated Hospital,ZheJiang Univercity

Phone: +86-13958054006

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
Sponsor
First Affiliated Hospital of Zhejiang University
Registry
ClinicalTrials.gov
Start date
4 March 2021
Est. completion
30 June 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Safety and tolerability of Paclitaxel Micelles for Injection in dose ascending and dose extension as measured by assessment of maximum tolerated dose (MTD) and dose limiting toxicity (DLT).; The recommended dose for the phase II study

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: 28 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