The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer

NCT06269445 | Recruiting Phase 4

• 1 other identifier: 2023-942-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  Time between the start of the trial and the onset of (any aspect of) tumour progression or death (from any cause).

  up to 5 years

Secondary Outcomes (6)

• Objective remission rate (ORR)

  up to 5 years

• Overall survival (OS)

  up to 5 years

• Disease Control Rate (DCR)

  up to 5 years

• Duration of ongoing remission (DOR)

  up to 5 years

• TRAEs

  up to 5 years

Study Arms (1)

Icaritin Combined With Bevacizumab and FOLFIRI

EXPERIMENTAL

Icaritin: 600 mg orally, bid; Bevacizumab: Intravenous infusion, 5 mg/kg per dose, every 14 days; FOLFIRI: ①Irinotecan: Irinotecan should be given on the first day of chemotherapy at a dose of 180mg/m2 by intravenous drip.The infusion time should be \>30-90min. ②Calcium folinate: give irinotecan at a dose of 400mg/m2 by intravenous drip in conjunction with irinotecan infusion, and the infusion time should be up to 2h. ③5-fluorouracil: give intravenous infusion at a dose of 400mg/m2 on the first day of chemotherapy, then give an intravenous drip at a dose of 1200mg/m2 for 2 days, the total amount of 2400mg/m2 , and continue to be infused for 46-48h.

Drug: Icaritin Combined With Bevacizumab and FOLFIRI

Interventions

Icaritin Combined With Bevacizumab and FOLFIRI DRUG

Bevacizumab and FOLFIRI are second-line treatment options for colorectal cancer; synergistic efficacy expected in combination with Icaritin

Icaritin Combined With Bevacizumab and FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ). Age ≥ 18 years. 2).Patients with unresectable advanced metastatic colorectal cancer confirmed by clinical diagnostic criteria and/or histopathological or cytological examination. Metastases include, but are not limited to the liver.
• ). Presence of clearly measurable (RECIST 1.1 compliant) liver metastases on imaging assessment (unresectable by MDT assessment).
• ). Patients who have failed prior first-line systemic systemic therapy, including bevacizumab.
• ).ECOG PS score 0-1. 6). Have normal organ function and meet the following criteria on laboratory tests within 7 days prior to initiation of therapy:
• Haemoglobin level \> 80 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
• Platelet count ≥50×10-9/L;
• Serum albumin ≥ 30 g/L;
• Total bilirubin ≤ 2 × upper limit of normal (ULN);
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5 × ULN;
• Alkaline phosphatase (ALP) ≤ 2.5 x ULN;
• creatinine ≤ 1.5 x ULN and creatinine clearance ≥ 50 ml/min. 7). Good swallowing function. 8). Coagulation function: international normalised ratio (INR) ≤ 1.5 x ULN or prothrombin time (PT)≤16s.
• ). Life expectancy ˃3 months. 10). Voluntary participation in this study and voluntary signing of informed consent.
• ). Men and women of gestational age must agree to use adequate contraception throughout the study and for 3 months after the end of treatment.

You may not qualify if:

• ). Pre-existing or coexisting other active malignant tumours (except for malignant tumours that have been curatively treated and have been free of malignancy that has received curative treatment and has been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).
• ). Concomitant administration of modern Chinese medicinal preparations for antitumour and anti-tumour indications.
• ). Patients who have received chemotherapy or anti-vascular endothelial growth factor receptor (VEGF) therapy.
• ). Patients receiving systemic chemotherapy, hormonal therapy, immunotherapy, approved proteins/antibodies or any experimental drugs or treatments (30 days) or radiotherapy (within 14 days).
• ). Tumour invasion of large blood vessels. 6). Significant cardiovascular compromise within 12 months prior to the first dose of study drug: e.g., New York Heart Association (NYHA) Class II or higher. Stroke, myocardial infarction or cerebral haemorrhage, or arrhythmia associated with haemodynamic instability; Corrected QT (QTc) interval prolongation \>480ms.
• ). Any surgical procedure within the last 28 days. 8). Bleeding from ruptured oesophageal or gastric varices within the last 2 weeks, or unconfirmed severe varices and bleeding in the judgement of the investigator.
• ). Bleeding or thrombotic disorders or on thrombolytic therapy, coagulation disorders; study intervention Clinically significant haemoptysis or tumour bleeding of any cause within 2 weeks prior to first dose.
• ). Patients with uncontrolled epilepsy, history of central nervous system disease or psychiatric disorders, hypertension.
• ). Active autoimmune disease requiring systemic therapy within the past 2 years.
• ). Clinically significant ascites on physical examination that cannot be controlled medically.
• ). Pregnant or breastfeeding female patients, or those unwilling to use contraception during the trial.
• ). Known hypersensitivity to Icaritin, Bevacizumab and chemotherapeutic drug components.
• ). Suspect that it may cause contraindication to the use of the drug, or affect the reliability of the study results, or place the patient at a disease or condition that places the patient at high risk for treatment complications, or affects the patient's adherence to the trial medication.
• ). Vulnerable populations, including those with mental illness, cognitive impairment, critically ill patients, illiteracy, etc.
• ). Presence of other reasons that the investigator considers inappropriate for participation in this study.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sheng Dai

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wang

CONTACT

13732236150; 21418531@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, head of medical affairs

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 21, 2024
• Study Start: January 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data is expected to be released on Dec 2025
• Access Criteria: Case Record Form

Locations

CN (1)