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New treatment option for Gastric Adenocarcinoma
Official title Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
ClinicalTrials.gov ID: NCT04047953
What this study is testing
What is Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1?
Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric adenocarcinoma.
Also referred to as Paclitaxel (albumin-bound) + Oxaliplatin + S-1, Nab-paclitaxel + Oxaliplatin + S-1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Physical condition and organ function allow for larger abdominal surgery.
You likely can't join if
- 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...
- 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.
See the full eligibility 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 /...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.