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A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases

NCT06218888•Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

To explore the Efficacy and Safety of Tislelizumab combined with fruquintinib and Chidamide in the treatment of unresectable or advanced microsatellite stabilized (MSS/pMMR) colorectal cancer with liver metastases

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged ≥ 18 years old and ≤ 75 years old.
•Expected survival time ≥ 18 weeks.
•Diagnosis of pMMR confirmed by PCR for microsatellite stability (MSS) or low microsatellite instability (MSI-L), or by immunohistochemistry for DNA mismatch repair (MMR) proteins, including MLH1, MSH2, MSH6 and PMS2 protein expression, which result in no protein deletion.
•Subjects with histologically and/or cytologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma with liver metastasis (excluding adenosquamous carcinoma mixed with other pathological types).
•ECOG PS score is in the range of 0\~1.
•Failure of previous treatment with fluorouracil, oxaliplatin, and irinotecan based chemotherapy, with imaging evidence (such as CT scans) or clinical evidence (such as cytological reports of new ascites or pleural effusion) demonstrating disease progression during or after treatment, or discontinuation of treatment due to toxicity intolerance.
•Subjects having adequate organ and bone marrow functions with laboratory test values within 7 days prior to enrollment meeting the following requirements, as follows:
•1. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L; platelet count (PLT) ≥ 100×109/L; hemoglobin level (HGB) ≥ 9.0 g/dL.
•2. Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in subjects without liver metastases, and ALT and AST ≤ 5.0 × ULN in subjects with liver metastases; serum albumin ≥ 25 g/L.
•3. Renal function: serum creatinine (Cr) ≤ 1.5 x ULN. 4) Patients with routine urine results showing urine protein \<2+ or routine urine testing showing urine protein ≥ 2+ at baseline should undergo 24-hour urine collection and 24-hour urine protein quantification \< 1 g.
+1 more criteria

Exclusion Criteria

•Prior exposure to any anti-PD-1 antibody, anti-PD-L1 antibody, HDAC inhibitor, or irinotecan.
•Receiving any investigational drug within 4 weeks prior to the first dose of the study drug.
•Concurrent participation in another interventional clinical study, except in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study.
•Receiving the last dose of antitumor therapy (chemotherapy, targeted therapy, tumor immunotherapy, or tumor embolization) within 3 weeks prior to the first dose.
•Receiving radiotherapy within 4 weeks prior to the first dose.
•Patients who have received radiotherapy more than 4 weeks prior to the first dose with any radiotherapy-related toxic reactions, such as radiation pneumonia, radiation hepatitis, radiation enteritis, including clinical symptoms only, or requiring glucocorticoid therapy.
•Use of immunosuppressive drugs within 4 weeks prior to the first dose, excluding topical glucocorticoids by nasal spray, inhalation or other routes or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/day prednisone or equivalent doses of other glucocorticoids).
•Receiving live attenuated vaccine within 4 weeks prior to the first dose or planning to receive during the study period.
•Major surgical procedure (craniotomy, thoracotomy or open heart surgery) or unhealed wound, ulcer or fracture within 4 weeks prior to the first dose.
•Presence of toxicity (excluding alopecia, non-clinically significant and asymptomatic laboratory abnormalities) from prior antineoplastic therapy not recovered to ≤ grade 1 by NCI common terminology criteriafor adverse events (CTCAE) Version 5.0 (NCI CTCAE Version 5.0) prior to the first dose.
+30 more criteria

Key Dates

Start Date

June 1, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

January 23, 2024

Enrollment

ESTIMATED participants

Conditions

Colo-rectal Cancer

Interventions

Tislelizumab

DRUG

Fruquintinib

DRUG

Chidamide

DRUG

Contacts

Li hui, bachelor

CONTACT

13600855801 Lihui7701@163.com

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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: January 23, 2024Data 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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A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases

Inclusion Criteria

Exclusion Criteria

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

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