A Phase II Prospective Trial of mXELOXIRI Reintroduction for mCRC

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT04508452
Phase
PHASE2
Status
Unknown

Conditions

  • Unresectable Metastatic Colorectal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The objective is to evaluate the efficacy and safety of reintroduction of modified XELOXIRI combined with molecular targeted drug in patients with metastatic colorectal cancer (mCRC)

Key Dates

Start date
May 18, 2020
Status verified
Jan 2021
Primary completion
Jun 1, 2022
Completion
Jun 1, 2023

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mXELOXIRI+Bev reintroduction
    Patients will receive mXELOXIRI+BEV as first-line therapy (to be repeated every 2 weeks for a maximum of 12 cycles), followed to initiate a MDT to determine whether to perform a surgery or receive maintenance therapy. Maintenance treatment: CAP+BEV. The following CAP+BEV therapy will be repeated in 2-week cycles. At the time of disease progression, patients will be re-introduced XELOXIRI plus bev at the same doses and schedule previously tolerated, for a maximum of 12 cycles. If no progression occurs during XELOXIRI plus bev, patients will receive maintenance CAP+BEV at the same dose used in the last cycle of the induction treatment.

Primary Outcome Measure

Reintroduction Rate [ Time Frame: Up to 18 months ]

Central Contacts