Combining Paclitaxel, Oxaliplatin, and S-1 for treating advanced gastric cancer

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

This study is testing a new combination of three drugs to see if it can help people with advanced stomach cancer become healthy enough for surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 95 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04047953 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a combination therapy using Paclitaxel (albumin-bound), Oxaliplatin, and S-1 for patients with initially unresectable or potentially resectable metastatic gastric adenocarcinoma. The approach aims to convert the disease to a state where surgical intervention may be possible. Participants will undergo treatment and be monitored for their response and any adverse effects. The study focuses on patients who meet specific health criteria and have a confirmed diagnosis of gastric adenocarcinoma.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma and a Karnofsky Performance Status Score of 70 or higher.

Not a fit: Patients with HER2 positive gastric adenocarcinoma or those whose physical condition does not allow for larger abdominal surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the chances of surgical resection and overall survival for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating gastric cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
* Pregnancy or breastfeeding woman.
* 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.
* Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
* 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.
* 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.
* Organ transplantation requires immunosuppressive therapy.
* Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases.
* 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).
* Those suffering from dihydropyrimidine dehydrogenase (DPD) deficiency are known.
* Those who are allergic to taxanes or any research ingredients.
* Those who received research medications or preparations/treatments (ie, participated in other trials) within 4 weeks prior to enrollment.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jiafu ji, MD — Peking University Cancer Hospital & Institute
• Study coordinator: Jiafu ji, MD

Conditions Gastric Adenocarcinoma; Paclitaxel; gastric cancer; conversion therapy