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The Effects of RFA in Combination With Second-line Chemotherapy and Bevacizumab on Unresectable CRLM

NCT03686254 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-09-26

No results posted yet for this study

Summary

Basing on the strong evidence from former researches, patients with CRLM can benefit from the treatment of bevacizumab combined with sencond-line chemotherapy. Recently, although with the popularization of RFA, the role that RFA plays in the long term survival of patients with metastatic colorectal cancer (CRC) is still confused. In this designed, randomized, controlled, prospective, and open clinical trial, the effectiveness of RFA combined with second-line chemotherapy + bevacizumab on unresectable CRLM is going to be evaluated compared with that of second-line chemotherapy + bevacizumab. After screened by inclusion and exclusion criteria, the eligible subjects will be randomly allocated into the experimental group-with the treatment of RFA + second-line chemotherapy + bevacizumab and control group-with the treatment of second-line chemotherapy + bevacizumab equally.

Conditions

  • Colorectal Neoplasms Malignant

Interventions

COMBINATION_PRODUCT

RFA, bevacizumab and second-line chemotherapy

Navigated by CT-ultrasound merged images, RFA is taken in the experimental arm at the first day of the first cycle during the second-line therapy. Bevacizumab is given to patients in all arms every 2 weeks (5mg/kg) or 3 weeks (7.5mg/kg), intravenous drip(VD). The second-line chemotherapies include FOLFIRI \[Irinotecan 180 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or irinotecan monotherapy (125 mg/m2 D1, 8, q3W or 180 mg/m2 D1, q2W), mFOLFOX6 \[Oxaliplatin 85 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or CapeOX (Oxaliplatin 130 mg/m2 D1+Capecitabine 1000 mg/m2 Bid D1-14, q3W)，or irinotecan+oxaliplatin (Oxaliplatin 85 mg/m2 D1+Irinotecan 200 mg/m2 D1, q3W). Among these strategies, the treatment cycle of FOLFIRI, irinotecan monotherapy and mFOLFOX6 is two weeks, while three weeks in CapeOX and irinotecan + oxaliplatin.

DRUG

Bevacizumab and second-line chemotherapy

Bevacizumab is given to patients in all arms every 2 weeks (5mg/kg) or 3 weeks (7.5mg/kg), intravenous drip(VD). The second-line chemotherapies include FOLFIRI \[Irinotecan 180 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or irinotecan monotherapy (125 mg/m2 D1, 8, q3W or 180 mg/m2 D1, q2W), mFOLFOX6 \[Oxaliplatin 85 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or CapeOX (Oxaliplatin 130 mg/m2 D1+Capecitabine 1000 mg/m2 Bid D1-14, q3W)，or irinotecan+oxaliplatin (Oxaliplatin 85 mg/m2 D1+Irinotecan 200 mg/m2 D1, q3W). Among these strategies, the treatment cycle of FOLFIRI, irinotecan monotherapy and mFOLFOX6 is two weeks, while three weeks in CapeOX and irinotecan + oxaliplatin.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Wangjun Liao · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03686254 on ClinicalTrials.gov