Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04047953
Other study ID # GC-conversion
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 10, 2019
Est. completion date November 2026

Study information

Verified date April 2023
Source Peking University Cancer Hospital & Institute
Contact Jiafu ji, MD
Phone 86-010-88196048
Email jiafuj@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 95
Est. completion date November 2026
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg,bid, d1-14( BSA<1.25m2,40mg;1.25m2=BSA=1.5m2,50mg;BSA>1.5m2,60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary R0 resection rate Proportion of patients who achieved R0 resection within 4 weeks following the operation
Secondary Progression free survival (PFS) the time from registration to the date of disease progression or death resulting from any cause. 5 years
Secondary overall survival (OS) the time from registration to the date of death resulting from any cause or the last follow-up visit. 5 years
Secondary Adverse Events(AEs) AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. until 28 days after the last study drug administration
See also
  Status Clinical Trial Phase
Recruiting NCT05977998 - A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology Phase 2
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT03257163 - Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer Phase 2
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Completed NCT01178944 - Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer Phase 2
Terminated NCT00209079 - Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma Phase 2
Terminated NCT02862535 - Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma Phase 1
Active, not recruiting NCT05008783 - A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma Phase 3
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Recruiting NCT04114136 - Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2
Completed NCT03196232 - Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer Phase 2
Completed NCT02891447 - Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer Phase 2
Completed NCT02864381 - Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2
Terminated NCT04604132 - Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma Phase 1/Phase 2
Completed NCT02830594 - Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer Phase 2
Recruiting NCT06038578 - A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer Phase 2
Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1
Recruiting NCT04581473 - Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection Phase 1/Phase 2