Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients

Phase 1

Not yet recruiting

• Conditions: Regorafenib; Raltitrexed; Colorectal Neoplasms; Third-line Treatment
• Interventions: Drug: Regorafenib; Drug: Raltitrexed

• Registration Number: NCT05426811
• Lead Sponsor: China Medical University, China

Brief Summary

This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.

Detailed Description

This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.This Phase Ib/II study consists of two parts, Phase Ib, an open-ended, single-arm, multi-centre, dose-escalation study evaluating regorafenib, and Phase II, an open-label, multi-centre study evaluating the efficacy and safety of regorafenib in combination with raltitrexed.The primary study endpoint: progression-free survival (PFS).The secondary end endpoints include ORR (overall effectiveness of tumour treatment)，DCR (disease control rate)，3 month/6 month/9 month/12 month survival OS%，OS (overall survival)，incidence and severity of adverse events (AEs), serious adverse events (SAEs).

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Last Update Submitted: 2022-06-24
• Last Update Posted: 2022-06-29
• Study Start: 2022-07-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regorafenib combined with Raltitrexed	Raltitrexed	Regorafenib: 120mg/d，Po，qd,d1-d21，Every 4 weeks Raltitrexed: 3mg/㎡，ivgtt，d1，Every 3 weeks
Regorafenib combined with Raltitrexed	Regorafenib	Regorafenib: 120mg/d，Po，qd,d1-d21，Every 4 weeks Raltitrexed: 3mg/㎡，ivgtt，d1，Every 3 weeks

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	one year	PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	one year	ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Disease Control Rate (DCR)	one year	Determined using RECIST v1.1 criteria.
Overall Survival (OS)	two years	Duration from the date of initial treatment to the date of death due to any cause.
Incidence and severity of adverse events (AE) and serious adverse events (SAE)	two years	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.