NCT04047953Recruiting
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 5 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 95 (estimated)
- First submitted
- 6 Aug 2019
- Start date
- 10 Sept 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04047953
What you commit to
- Study type: Interventional
- Planned participants: 95
- From 10 Sept 2019 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
- Organ transplantation requires immunosuppressive therapy.
- Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases.
- Those who received research medications or preparations/treatments (ie, participated in other trials) within 4 weeks prior to enrollment.
Other illness
- Patients with ascites and positive abdominal free cancer cells.
- There are other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- Those with a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe drug-affected arrhythmias, or there is a history of myocardial infarction in the last 12 months.
- Upper gastrointestinal stagnation or abnormal physiological function or malabsorption syndrome may affect the absorption of S-1.
- Those who are allergic to taxanes or any research ingredients.
Lab values
- Moderate or severe renal impairment \[creatinine clearance equal to or lower than 50ml/min (calculated according to Cockcroft and Gault equations), or serum creatinine \> upper normal limit (ULN).
Age
- Women of childbearing age who had a positive pregnancy test at baseline or who did not undergo a pregnancy test. Menopausal women must be stopped for at least 12 months to ensure that no pregnancy is possible.
Other
- Pregnancy or breastfeeding woman.
- Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
- It is known to have peripheral neuropathy ≥ NCI CTC AE grade 2. However, only the deep sputum reflex (DTR) disappears and the patient does not have to be excluded.
- Those suffering from dihydropyrimidine dehydrogenase (DPD) deficiency are known.
Who the study is looking for
- Age of 18-75 years; male or female.
- Karnofsky Performance Status Score ≥70.
- Histological diagnosis of gastric adenocarcinoma, HER2 expression negative.
- The initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, potentially resectable factor includes a single liver metastases, localized abdominal para-aortic lymph node (16a1 / b2) metastasis or positive abdominal free cancer cells.
- Physical condition and organ function allow for larger abdominal surgery.
- Subject baseline blood routine and blood biochemistry indexes meet the following criteria: hemoglobin(HB) ≥90 g/L; absolute neutrophil count(ANC) ≥1.5×109 /L; platelet count(PLT) ≥100×109 /L; alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN); total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); Serum albumin≥30g/L.
- Echocardiographic scan confirmed left ventricular ejection fraction (LVEF) ≥ 50%.
- No serious accompanying disease lead to a survival period of \<5 years.
- Agree and be able to follow the protocol during the study period.
- Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.