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mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer

mFOLFOX6 Combined With Dalpiciclib(SHR6390) in Patients With Metastatic Colorectal Cancer (FIND): A Single-arm, Phase IIa Study.

NCT05480280•Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

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.

Detailed Description

1. Primary study end point: To evaluate the safety and objective response rate (ORR) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment. 2. Secondary study end Point: To evaluate the progression-free survival (PFS) and overall survival (OS) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects voluntarily sign informed consent
•Age: from 18 to 70 years old
•Definite histological evidence of colorectal adenocarcinoma
•ECOG 0-1
•Advanced or metastatic colorectal cancer (AJCC/UICC stage IV) is confirmed by enhanced CT of the chest, abdomen and pelvis, with evaluable lesions
•Tumor progression or intolerable toxicity after previous standard treatment; Tumor progression during adjuvant therapy or within 6 months after completion of adjuvant therapy was considered as first-line treatment (Standard treatment must include all of the following drugs: fluorouracil, irinotecan, and oxaliplatin; With or without anti-VEGF monoclonal antibody (bevacizumab); Anti-EGFR treatment(cetuximab or panitumumab) in left colorectal RAS (KRAS/NRAS) wild-type subjects)
•The bone marrow, liver and kidney function satisfies the following conditions within 7 days before treatment (including day 7):
•Hemoglobin ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥75×109/L; aspartate aminotransferase (AST) ≤ 2 upper limit of normal (ULN), glutaminate alanine transaminase (ALT) ≤ 3 ULN, total bilirubin ≤ 1.5 ULN, serum creatinine ≤ 1.5 ULN
•Peripheral neurological lesions recover (≤ grade 1) before enrollment
•Subjects should not participate in other clinical trials during the study period
+1 more criteria

Exclusion Criteria

•Complicated with obstruction, active bleeding or perforation and requiring emergency surgery or stent placement
•Existing or coexisting other active malignancies
•Previously CDK inhibitors treatment
•Major surgery or severe trauma such as laparotomy, thoracotomy or laparoscopic organ removal within the previous 4 weeks
•Active coronary artery disease, severe/unstable angina or newly diagnosed angina or myocardial infarction in the past 12 months
•Thrombotic or embolic events occurred within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism or deep vein thrombosis
•New York Heart Association (NYHA) Class II or higher Congestive heart failure
•Presence of clinically symptomatic third space effusion (eg, massive pleural or ascites) that cannot be controlled by drainage or other methods
•Human immunodeficiency virus (HIV) infection or diseases associated with acquired immunodeficiency syndrome (AIDS)
•Active inflammatory bowel disease or other colorectal disease leading to chronic diarrhea
+5 more criteria

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

July 20, 2022

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

February 28, 2023

Enrollment

ESTIMATED participants

Conditions

Advanced/Metastatic Colorectal Cancer

Interventions

Dalpiciclib

DRUG

Oxaliplatin injection

DRUG

Calcium folinate

DRUG

5-fluorouracil

DRUG

Contacts

Xiaojian Wu, Ph.D

CONTACT

+86-13760608396 wuxjian@mail.sysu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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