colorectal cancer
Conditions
Interventions
study group:Capecitabine
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 years and more; 2. Pathologically diagnosed as colorectal adenocarcinoma; 3. Have a diagnosis of Stage IV CRC with metastases to the liver only by thoracoabdominal enhanced CT or MRI examination and have undergone one of the following four treatment scenarios: (1) A primary CRC lesion(s) in the colon and/or rectum and synchronous liver metastases, which were treated with surgery with curative intent for both primary and metastatic lesions and at least 3 months of neoadjuvant, adjuvant, or perioperative chemotherapy including a fluoropyrimidine and either oxaliplatin or irinotecan. Total chemotherapy administered, including that administered prior to and after liver resection, should not exceed 6 months (12 cycles for two weeks regimen; 8 cycles for 3 weeks regimen). (2) Metachronous liver metastases: A primary CRC lesion(s) in the colon and/or rectum, which was treated with surgery with curative intent and at least 3 months adjuvant chemotherapy (fluoropyrimidine alone or combined with oxaliplatin) and > 12 months after completing treatment for primary CRC, developed liver metastases, which were treated with surgery with curative intent and a second course of chemotherapy lasting at least 3 months, including a fluoropyrimidine and either oxaliplatin or irinotecan. The second round of chemotherapy administered for the treatment of liver metastases should not exceed 6 months; (3) Metachronous liver metastases: A primary CRC lesion(s) in the colon and/or rectum, which was treated with surgery with curative intent and didnt receive adjuvant chemotherapy, developed liver metastases, which were treated with surgery with curative intent and chemotherapy lasting at least 3 months, including a fluoropyrimidine and either oxaliplatin or irinotecan. The chemotherapy administered for the treatment of liver metastases should not exceed 6 months; (4) Metachronous liver metastases: A primary CRC lesion(s) in the colon and/or rectum, which was treated with surgery with curative intent and less than 6 months adjuvant chemotherapy (fluoropyrimidine alone or combined with oxaliplatin) and 6-12 months after completing treatment for primary CRC, developed liver metastases, which were treated with surgery with curative intent and a second course of chemotherapy lasting at least 3 months. The regimen should be different from previous chemotherapy regimen. The second round of chemotherapy administered for the treatment of liver metastases should not exceed 6 months; (4) A primary CRC lesion(s) in the colon and/or rectum and liver metastases, which were transformed into resectable liver metastases, received 1 tumor, tumor size >5 cm, CEA > 3 × upper limit of normal); (7) The chemotherapy efficacy should be CR/PR/SD according to RECIST 1.1 criteria if there is pr
Exclusion criteria
Exclusion criteria: 1. The primary lesion or liver metastases were not treated with surgery with curative intent, or have tumor recurrence at baseline radiological examination before randomization; 2. Have had anti-cancer treatment following liver resection that exceeded a duration of 6 months; 3. The treatment efficacy after chemotherapy was PD or SD with tumor diameter increased by 10% according to RECIST 1.1 criteria; 4. Have been treated with biologics (eg, antibodies targeting vascular endothelial growth factor or epidermal growth factor receptor) after liver resection unless the administration of the biologic started prior to liver resection and continued after liver resection only to complete a pre-specified number of cycles; 5. Completed their last dose of chemotherapy or had their last cancer surgery more than 8 weeks, whichever came later, prior to randomization; 6. Have extra-hepatic metastatic disease. Suspicious lesions should be rigorously evaluated with other imaging techniques and/or biopsy to exclude extra-hepatic metastatic disease; 7. Have had prior or concurrent cancer distinct in primary site or histology from CRC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer, or superficial bladder tumors classified as noninvasive tumor (Ta), carcinoma in situ (Tis), or tumor invades lamina propria (T1); 8. Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and/or hormonal therapy within 4 weeks prior to initiation of study treatment; 9. Have unresolved toxicity higher than National Cancer Institute-Common Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed to any prior therapy/procedure, excluding alopecia and/or oxaliplatin-induced neurotoxicity = Grade 2 and hemoglobin = 9 g/dL as per inclusion criteria; 10. Have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment; 11. Are pregnant; 12. Are breastfeeding; 13. Are unable to swallow oral tablets (crushing of study treatment tablets is not allowed); 14. Have congestive heart failure classified as New York Heart Association Class 2 or higher. Have had unstable angina (angina symptoms at rest) or new-onset angina = 3 months prior to screening. Have had a myocardial infarction < 6 months prior to initiation of study treatment. Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin; 15. The uncontrolled infection, diarrhea, and bowel obstruction; 16. Have a known history of human immunodeficiency virus infection; 17. Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy; 18. Have a seizure disorder requiring medication; 19. Have a history of organ allograft; 20. Have renal failure requiring hemodialysis or peritoneal dialysis; 21. Have any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subjects participation in the study or evaluation of the study results; 22. Have any malabsorption condition; 23. Have a known hypersensitivity to capecitabine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Countries
China
Contacts
Public ContactMeng Qiu
West China Hospital, Sichuan University
Outcome results
None listed