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A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer

NCT06363552 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-04-12

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer.

Conditions

Interventions

DRUG

SC0191

The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle.

DRUG

SC0191 + Bevacizumab

1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Bevacizumab injection is administered intravenously at a dose of 5mg/kg on day 1 and day 15 of each treatment cycle.

DRUG

SC0191 + 5-FU/LV

1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Calcium folinate 400mg/m2 intravenous infusion (over 2 hours or more), on the first day, followed by 5-fluorouracil 400mg/m2 intravenous bolus injection, then continuous intravenous infusion of 1200mg/m2/day for 2 days.

Sponsors & Collaborators

  • Tianshu Liu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-04-30
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06363552 on ClinicalTrials.gov