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The Efficacy of Bevacizumab Combined With m-FOLFOXIRI in Borderline Resectable Colorectal Liver Metastases

ABSTRACT: This single-arm study will evaluate the resection rate of liver metastases in patients with metastatic colorectal cancer and borderline unresectable liver metastases receiving treatment with bevacizumab in combination with modified-FOLFOXIRI as first line treatment. Patients will receive bevacizumab (5 mg/kg) plus modified-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, and fluorouracil 2400 mg/m2 as a 46-h continuous infusion) every 14 days as neoadjuvant chemotherapy regimen. This study treatment will continue until surgery, disease progression, unacceptable toxicity, or patient refusal.

DISEASE(S): Neoplasm Metastasis,Colorectal Cancer

PROVIDER: 2287221 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES

Project description:Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline and/or high risk resectable colorectal cancer liver metastases

| 2162638 | ecrin-mdr-crc

Immune microenvironment evolution and tumor metabolism reprograming during treatment of Bevacizumab containing regimen in CLM patients

Project description:We examined how the immune microenvironment molds tumor evolution in a longitudinal dataset of colorectal cancer liver metastases. Through multiplexed analyses, the immune microenvironment exerts a strong selection pressure during treatment of CLM tumor. Increasing infiltration of T cell were associated with favorable outcomes and sensitive response to chemotherapy ± Bevacizumab. Activation of fatty acid metabolism, xenobiotic metabolism, insulin receptor signaling pathway and neutrophils infiltration were observed in progressive tumors. TCR diversity in response metastatic regions was significantly increased compared with non-responder. Bevacizumab containing regimen facilitated T cell infiltrating to the tumor microenvironment which might consequently benefit from checkpoint immunotherapy. In responding patients, mutation load from plasma were reduced from baseline, but changed slightly in tumor tissues. This integrative and comparative omics analysis provides a new paradigm for understanding the evolution and treatment resistance of colorectal cancer liver metastases, with implications for identifying ways to advance treatment regimen and monitoring treatment response of colorectal cancer liver metastases.

2020-03-08 | GSE136114 | GEO

Progression of liver tumor was promoted by tris(1,3-dichloro-2-propyl)phosphate through the induction of inflammatory responses in krasV12 transgenic zebrafish

Project description:In this study, krasV12 genetically modified zebrafish, Tg(fabp10:rtTA2s-M2; TRE2:EGFP-krasG12V), an inducible liver tumor model, was used to evaluate the promotion potential of TDCIPP for liver tumor. Briefly, krasV12 transgenic females were exposed to 0.3 mg/L TDCIPP, 20 mg/L doxycycline (DOX) and a binary mixture of 0.3 mg/L TDCIPP with 20 mg/L DOX, and liver size, histopathology, and transcriptional profiles of liver were tested. Treatment with TDCIPP increased the liver size and caused more aggressive hepatocellular carcinoma (HCC). Furthermore, compared with the exposure to DOX, TDCIPP in the presence of DOX up-regulated the expression of genes relevant with salmonella infection and the toll-like receptor signaling pathway, implying an occurrence of inflammatory reaction, which was sustained by the increase in the amount of infiltrated neutrophils in the liver of Tg(lyz:DsRed2) transgenic zebrafish larvae. Collectively, our results suggested that TDCIPP could promote the liver tumor progression by induction of hepatic inflammatory responses.

2019-06-21 | GSE133076 | GEO

Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases

Project description:Evidence suggests that the addition of cetuximab or bevacizumab to doublet regimens could improve response rate and resectability rate of liver metastases and survival in colorectal liver metastases (CRLM). Moreover, it is observed that FOLFOXIRI yields higher response and resection rates compared with doublet regimens. However, which is better in conversion therapy of RAS/BRAF wild-type initially unresectable CRLM, FOLFOXIRI plus cetuximab or bevacizumab, remains unknown. In this study, RAS/BRAF wild-type colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be randomised between modified FOLFOXIRI (mFOLFOXIRI) plus cetuximab and mFOLFOXIRI plus bevacizumab. Patient imaging will be reviewed for resectability by MDT, consisting of at least one radiologist and three liver surgeons every assessment. MDT review will be performed prior to randomization as well as during treatment, as described in the protocol.

| 2362223 | ecrin-mdr-crc

Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer(WJOG9216G)

Project description:Interventions: Arm A: FOLFIRI+Rmab treatment Rmab:8 mg/kg/day1 l-leucovorin (l-LV):200 mg/m2/day1 irinotecan (IRI): 180 mg/m2/day1 bolus 5-FU:400 mg/m2/day1 infusional 5-FU:2400 mg/m2/day1-3 Every 2 eeks Arm B: FOLFOXIRI+Rmab treatment Induction therapy: 8 courses (maximum of 12 courses) Rmab:8 mg/kg/day1 IRI:165 mg/m2/day1 l-LV:200 mg/m2/day1 oxaaliplatin (OX):85 mg/m2/day1 infusional 5-FU: 3200 mg/m2/day1-3 Every 2 weeks Maintenance therapy 5-FU/l-LV+Rmab, every 2 week Primary outcome(s): Objective response rate Study Design: Parallel Randomized

| 2641746 | ecrin-mdr-crc

Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11

Project description:Interventions: SOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L-OHP 130 mg/m2/triweekly TS-1 80,100,120 mg/twice/day 1-14, following one week off XELOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L-OHP 130 mg/m2/triweekly Capecitabine 2400-4200 mg/twice/day 1-14, following one week off Primary outcome(s): Progression-free survival (PFS) Study Design: Parallel Randomized

| 2622332 | ecrin-mdr-crc

A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer

Project description:Interventions: To undergo modified folfox 6 regimen [5-fluorouracil 2.4 g/m2 (24-h continuous infusion), l-leucovorin 200 mg/m2 (2-h intravenous infusion), and oxaliplatin 85 mg/m2 (2-h intravenous infusion) every 2 weeks] for 24 weeks as adjuvant treatment after resection of liver metastases from colorectal cancer. Primary outcome(s): disease free survival side effect Study Design: Single arm Non-randomized

| 2616496 | ecrin-mdr-crc

Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer (WJOG9216G)

Project description:Interventions: Arm A: FOLFIRI plus ramucirumab (Rmab) treatment - Rmab: 8 mg/kg/day1 - l-leucovorin (l-LV): 200 mg/m2/day1 - irinotecan (IRI): 180 mg/m2/day1 - bolus 5-FU: 400 mg/m2/day1 - infusional 5-FU: 2400 mg/m2/day1-3 Every 2 weeks Arm B: FOLFOXIRI plus Rmab treatment Induction therapy: 8 courses (maximum of 12 courses) - Rmab: 8 mg/kg/day1 - IRI: 165 mg/m2/day1 - l-LV: 200 mg/m2/day1 - oxaliplatin (OX): 85 mg/m2/day1 - infusional 5-FU: 3200 mg/m2/day1-3 Every 2 weeks Maintenance therapy: 5-FU/l-LV+Rmab, every 2 weeks Primary outcome(s): Objective response rate Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2614896 | ecrin-mdr-crc

mFOLFOXIRI+Bev vs. mFOLFOX6+Bev for RAS Mutant Unresectable Colorectal Liver-limited Metastases

Project description:Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by conversion therapy. However, the optimal regimen of conversion therapy for RAS mutant patients has not been defined. In this study colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with RAS mutant and BRAF wild type will be randomised between modified FOLFOXIRI (mFOLFOXIRI) plus bevacizumab and modified FOLFOX6 (mFOLFOX6) plus bevacizumab. Patient imaging will be reviewed for resectability by MDT, consisting of at least one radiologist and three liver surgeons every assessment. MDT review will be performed prior to randomization as well as during treatment, as described in the protocol.

| 2369422 | ecrin-mdr-crc

A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER

Project description:Interventions: FOLFOXIRI+Bevacizumab (until 12 courses) 5-FU+Levofolinate+Bevacizumab (after 13 courses) Bevacizumab 5mg/kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly FOLFOXIRI+Cetuximab (until 12 courses) 5-FU+Levofolinate+etuximab (after 13 courses) Cetuximab (first time) 400 mg/m2/week Cetuximab (after 2nd time) 250 mg/m2/week Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): DpR: Deepness of Response Study Design: Parallel Randomized

| 2633522 | ecrin-mdr-crc

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