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UNKNOWNPHASE2

The Combination of Fruquintinib, Tislelizumab and Stereotactic Ablative Radiotherapy in Metastatic Colorectal Cancer(RIFLE)

A Phase Ⅱ Trial of Multisite Stereotactic Ablative Radiotherapy (SABR) Combined With Fruquintinib and Tislelizumab in Metastatic Colorectal Cancer

NCT04948034•Fudan University

View on ClinicalTrials.gov

Summary

This is a prospective, single-center, single-arm phase II clinical trial.This study aims to evaluate the safety and tolerability of stereotactic ablative radiotherapy (SABR) in combination with Fruquintinib and Tislelizumab, and to examine the impact of the combination therapy on tumor control, long-term survival and quality of life in patients with Metastatic colorectal cancer. A total of 68 metastatic colorectal cancer patients who have failed the first-line standard treatment, will be recruited and receive multisite SABR(8-12 Gy, 4-5 times) followed by fruquintinib(5mg, qd) and tislelizumab(200mg, q3w) within two weeks from completion.The overall response rate (ORR), disease control rate(DCR), progression-free survival(PFS) and overall survival(OS) will be analyzed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged over 18 years old, regardless of gender
•Fully informed and willing to provide written informed consent for the trial
•ECOG performance status 0-1
•Has an investigator determined life expectancy of at least 6 months
•Histologically or cytologically confirmed stage IV colorectal cancer (UICC 8th version)
•Has at least 2 measurable oligometastatic lesions on imaging (RECIST version 1.1). One will be treated with SABR and the other will be biopsied and evaluated against RECIST 1.1.
•Has progressive disease after receiving first-line standard antitumor therapy (chemotherapeutic agents including fluorouracil, oxaliplatin and irinotecan); previous neoadjuvant or adjuvant pelvic area radiotherapy is allowed; subjects included in the safety introduction phase may include third-line treatment or above, but these subjects will not be included in the final statistical analysis.
•Subjects receiving adjuvant oxaliplatin should progress during adjuvant therapy or within 6 months after completion.
•Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.
•Subjects who withdraw from standard treatment before disease progressing due to unacceptable toxicity and exclude the use of the same drug are also allowed to be included.
+1 more criteria

Exclusion Criteria

•Pregnant or lactating women
•The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years excluding adequately treated non-melanoma skin cancer, carcinoma in situ of cervix and superficial bladder tumor (non-invasive tumor, or carcinoma in situ, or T1)
•Baseline laboratory indicators do not meet the following criteria: neutrophils ≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L , ALT ≤2.5 ULN, AST ≤2.5 ULN, Cr≤ 1.5 ULN or creatinine clearance rate \<50ml/min, TBIL ≤1.5 ULN, APTT ≤1.5 ULN, PT ≤1.5 ULN (the criteria of patients with liver metastasis: PLT ≥80×10\^9/L, ALT ≤5 ULN, AST ≤5 ULN, TBIL ≤2.5 ULN)
•Serious electrolyte abnormalities
•Urinary protein ≥ 2+, or 24-hour urine protein ≥1.0g/24h
•Uncontrolled hypertension: SBP \>140mmHg or DBP \> 90mmHg
•Receiving radiotherapy within 4 weeks
•Receiving anti-VEGF or anti-EGFR therapy within 4 weeks
•Stroke event or transient ischemic attack occurred within 12 months
•A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months
+6 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 23, 2021

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2023

Last Updated

August 27, 2021

Enrollment

ESTIMATED participants

Conditions

Metastatic Colorectal Cancer

Interventions

Stereotactic Ablative Radiotherapy (SABR)

RADIATION

Fruquintinib

DRUG

Tislelizumab

DRUG

Contacts

Zhen Zhang, MD, PHD

CONTACT

18801735029 zhen_zhang@fudan.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: August 27, 2021Data 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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The Combination of Fruquintinib, Tislelizumab and Stereotactic Ablative Radiotherapy in Metastatic Colorectal Cancer(RIFLE)

Inclusion Criteria

Exclusion Criteria

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