Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab (NCT03698461) | Clinical Trial Compass
CompletedPhase 2
Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab
South Korea20 participantsStarted 2019-05-15
Plain-language summary
Liver is the most common site of metastases from colorectal cancer. Neoadjuvant chemotherapy with targeted agents is usually recommended for borderline-resectable liver metastases that are technically difficult to resect for conversion to resectable disease and control of metastatic spread. However, the prognosis of these patients are still poor, and long term disease-free survival over 3 years is rare and \<20%. More effective measures to prevent recurrence are needed before or after resection of colorectal liver metastases.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Have provided written informed consent prior to any study specific procedures
✓. Willing and able to comply with the protocol
✓. ≧ 20 years of age at the time of signing Informed Consent Form
✓. Eastern Cooperative Oncology Group (ECOG) status of ≤1
✓. Liver metastases from colorectal adenocarcinoma confirmed through biopsy
✓. Liver metastatic lesions should be considered to be potentially resectable after conversion chemotherapy by multi-disciplinary team and should meet one of the following criteria:
✓. Measurable by RECIST criteria 1.1.
Exclusion criteria
✕. Extrahepatic metastases that are not candidates for treatment of curative aim (e.g. resection, radiation or radiofrequency ablation)
✕
What they're measuring
1
Serial changes in Cluster of Differentiation(CD) 8+ T cell densities
Timeframe: Baseline, Day15 of first atezolizumab administration, and after at least 6 cycles (each cycle is 14days)
. Presence of central nervous system (CNS) metastases
✕. Concurrent or previous history of another primary cancer within 3 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanomatous skin cancer, superficial bladder cancer (pTis or pT1) and curatively treated thyroid cancer of any stage. Concurrent, histologically confirmed, unresected thyroid cancer without distant metastasis could be allowed with the agreement of the principal investigator.
✕. Chronic alcoholic hepatitis or cirrhosis
✕. Chronic hepatitis B, defined as HBV DNA (\> 2,000 IU / mL) and ALT\> upper limit of normal range, must be treated with antiviral drugs before enrollment to reach appropriate viral suppression (HBV DNA \<2000 IU / mL), and the antiviral drugs must be maintained during the study treatment period and for 6 months after the last dose of study treatment.
✕. Prior chemotherapy for metastatic disease
✕. Uncontrolled medical illness congestive heart failure, myocardial infarction within 6 months including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months