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mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer

NCT05480280 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-28

No results posted yet for this study

Summary

This is an prospective, single-center, single-arm, Simon's two-stage design, phase IIa study for advanced/metastatic colorectal cancer (CRC) who had failed or were intolerant to standard treatment. This study aims to evaluate the safety and efficacy of mFOLFOX6 combined with dalpiciclib (SHR6390) in the treatment of advanced/metastatic colorectal cancer.

Conditions

  • Advanced/Metastatic Colorectal Cancer

Interventions

DRUG

Dalpiciclib

Dalpiciclib is orally administered at 125mg qd for 21 days and discontinue for 7 days.

DRUG

Oxaliplatin injection

85mg/m², ivdrip, D1

DRUG

Calcium folinate

400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1

DRUG

5-fluorouracil

400mg/m², iv, D1; and 2400mg/m², civ, 46-48h

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xiaojian Wu, Ph.D · Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05480280 on ClinicalTrials.gov