Predictive Factors for Outcomes of Fruquintinib Plus Immunotherapy in Colorectal Cancer

NCT05635149 | Unknown

• 1 other identifier: UNION00168
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study was an observational cohort study to investigate the efficacy predictors of fuquinitinib combined with anti-PD-1 monoclonal antibody for third-line treatment and above in Chinese patients with advanced colorectal cancer.

Conditions

Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to the first documented disease

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year

• Adverse Event (AEs)

  from the date of first dose to the 30 days post the last dose

• Gut microbiome analysis

  16S ribosomal RNA (rRNA) sequencing for the baseline fecal samples of some patients

Other Outcomes (1)

• Exploratory endpoint

  from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year

Study Arms (2)

Fruquintinib and anti-PD-1 plus radiotherapy

Fruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off. anti-PD-1 antibody is administrated as 200mg once every 3 weeks. Patients with isolated or localized metastasis will receive radiotherapy.

Radiation: radiotherapy

Fruquintinib and anti-PD-1 alone

Fruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off. anti-PD-1 antibody is administrated as 200mg once every 3 weeks.

Interventions

radiotherapy RADIATION

In radiotherapy group, the modality of radiotherapy was conventional radiotherapy (CRT) or stereotactic body radiotherapy (SBRT) for cancer.

Also known as: drug, Fruquintinib and anti-PD-1

Fruquintinib and anti-PD-1 plus radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese adults, both male and female, with histologically confirmed metastatic or unresectable MSS/MSI-L/pMMR colorectal adenocarcinoma refractory to or intolerant of fluorouracil, oxaliplatin and irinotecan based systemic treatment, were enrolled in the study. Demographic information (i.e., age and gender) was collected.

You may qualify if:

• Signed the Informed Consent Form
• Ages: 18-75 Years (concluding 18 and 75 Years)
• Pathologically confirmed unresectable metastatic colorectal cancer
• Failure to 2st line therapy
• pMMR/MSS type
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy greater than 3 months
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan, larger than 20 mm in diameter by conventional CT scan) according to RECIST1.1
• Sufficient organ functions as follows (any blood transfusion or cell growth factor use within 14 days before enrollment is not allowed):
• Absolute Neutrophil Count (ANC) ≥1.5×109/L Platelet Count of ≥175×109/L; Hemoglobin≥90g/L; Total Bilirubin (TBIL) ≤1.5 x ULN; ALT and /or AST\<1.5 x ULN; If there is liver metastasis, then ALT and/or AST\<3.0 x ULN; Serum Creatinine (SCr) ≤1.5×ULN; Endogenous creatinine clearance rate ≥50ml / min；
• Man and woman who childbearing potential agrees to use adequate contraception
• Willingness to provide enough tumor tissues for PD-L1 expression test

You may not qualify if:

• Patients could not obey the study protocol.
• Previous therapy with VEGFR Inhibitor or anti-PD-1 antibody.
• Other malignancy within 5 years prior to study enrolment, except for cervical carcinoma in situ, basal or squamous cell skin cancer.
• Known brain or CNS metastases.
• Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment.
• Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
• Uncontrolled malignant ascites.
• Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade \> 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) \< 50%.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Participation in another clinical trial with any experimental drug within 4 weeks prior to enrollment.
• Clinically significant electrolyte abnormalities judged by researchers.
• Systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg regardless of any antihypertensive drugs.
• Poorly controlled diabetes before enrollment.
• Any factors that influence the usage of oral administration and patients cannot take fruquintinib orally.
• Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI, or other conditions that may cause GI bleeding and perforation as determined by the investigator.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Min Jin

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• Cheng M, Jin M, Yang S, Zhao L, Yu D, Lin Z, Li P, Huang C, Liu J, Wang J, Xue J, Ma H, Hu J, Yang K, Zhang T, Liu H. Effect of radiotherapy exposure on fruquintinib plus sintilimab treatment in refractory microsatellite stable metastatic colorectal cancer: a prospective observation study. J Immunother Cancer. 2025 Jan 4;13(1):e009415. doi: 10.1136/jitc-2024-009415.

  PMID: 39755582 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Baseline feces of the enrolled patients was collected

MeSH Terms

Interventions

Radiotherapy; Pharmaceutical Preparations; HMPL-013

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Hongli Liu, PhD

CONTACT

+86-027-85871962; hongli_liu@hust.edu.cn

Min Jin, PhD

CONTACT

18807108606; minjin86@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)