Status:
UNKNOWN
A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer
Lead Sponsor:
LiNing
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in...
Detailed Description
In 2019, CSCO guidelines grade I recommend gastric or gastroesophageal junction adenocarcinoma patients, after D2 R0 resection, whose postoperative pathological stage was III treated with XELOX as an ...
Eligibility Criteria
Inclusion
- Have signed the informed consent and can comply with the visit and related procedures stipulated in the program
- Age ≥18 years old and ≤75 years old
- D2 radical resection was performed within 21-60 days before the beginning of the first cycle of chemotherapy in this clinical study
- Preoperative neoadjuvant chemotherapy was not performed and Gastric and gastroesophageal junction adenocarcinoma (including signed-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) at stage IIIB and IIIC were confirmed by postoperative pathological staging. Note: the presence of distant metastases should be confirmed by a CT or MRI scan.ECT should be performed if bone metastases are suspected.If peritoneal metastases are suspected, laparoscopy should be performed
- Postoperative ECOG score was 0 or 1
- Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without blood transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without granulocyte stimulating factor treatment, and hemoglobin ≥ 90 g/L
- Bilirubin ≤ 1.5 times of the upper limit of normal value, glutamic oxalacetic transaminase and glutamic-pyruvic transaminase ≤ 2.5 times of the upper limit of normal value
- Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR\>45 ml/min
- Serum albumin ≥ 25 g/L (2.5g /dL)
- INR or PT ≤ 1.5 times ULN
- Hepatitis b surface antigen positive patients need to be tested for hepatitis b DNA virus quantitative detection, only \< the upper limit of the normal detection value can be included in the group, and should long-term use of anti-hepatitis b drugs
- Tumor specimens can be provided for consultation (if the patient's surgical specimen comes from another hospital), protein and gene testing
Exclusion
- Postoperative wound healing is poor and chemotherapy is not appropriate to start
- Recurrent patients or suspected peritoneal metastases after radical surgery
- Known DPD enzyme deficiency
- Allergy to, or history of severe allergy to, or contraindication to any of the experimental drugs or its excipients
- Patients who are expected to require major surgery during the study period
- Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT-confirmed active pneumonia
- Tested positive for HIV
- Active hepatitis b or c
- Only liquid diet was allowed after the operation, with BMI \<18kg/m2
- Uncontrolled pain
- A history of antitumor drug therapy other than radical surgery
- Severe infection in the active stage or with poor clinical control
- Use of hormones is contraindicated
- Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial
- Uncontrollable increase in blood pressure or blood sugar
- A history of other malignancies within 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer
- Distant metastases are known
- Peripheral neuropathy ≥ NCI CTCAE grade 2
- Serum albumin \< 2.5 g/dL
- Chronic enteritis
- Any other disease for which there is evidence of a need to limit the use of experimental drugs
- Participate in additional trials up to 30 days before the trial or plan to participate in additional trials while the trial is ongoing
- Receive other experimental drugs up to 28 days before the start of the trial
- Women who are pregnant or nursing, or who plan to become pregnant within five months of the end of treatment. Women of childbearing age should receive a blood/urine pregnancy test 7 days before the start of the trial
- Clinically significant active bleeding
- Patients who have trouble swallowing tablets
- Previous allogeneic bone marrow transplant or organ transplant
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04351867
Start Date
September 1 2020
End Date
June 1 2024
Last Update
July 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008