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

Colorectal Cancer Clinical Trial

Official title:

The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer: A Prospective, Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269445
• Other study ID #: 2023-942-01
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2024
• Source: Sir Run Run Shaw Hospital
• Contact: Fei Wang
• Phone: 13732236150
• Email: 21418531[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

At present, second-line only targeting combined with chemotherapy is the main treatment option, and the choice of treatment modality is limited, with the immunotherapy rise of immunotherapy, the mode of combining immunotherapy on the basis of existing first- and second-line chemotherapy combined with targeting is also being actively explored, but no positive results of large-scale phase III clinical studies have been reported yet. Meanwhile, there is no solution to the the problem of pro-inflammatory factor release. Therefore, it is necessary to consider the combination of a drug with a better safety profile and target-immunity synergistic effect. A combination of drugs with better safety and target-immunity synergistic effect could be considered as a safer and more effective treatment option for patients with liver metastases from advanced colorectal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1). 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.

3). Presence of clearly measurable (RECIST 1.1 compliant) liver metastases on imaging assessment (unresectable by MDT assessment).

4). Patients who have failed prior first-line systemic systemic therapy, including bevacizumab.

5).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:

1. Haemoglobin level > 80 g/L;

2. Absolute neutrophil count (ANC) = 1.5 x 109/L;

3. Platelet count =50×10-9/L;

4. Serum albumin = 30 g/L;

5. Total bilirubin = 2 × upper limit of normal (ULN);

6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 5 × ULN;

7. Alkaline phosphatase (ALP) = 2.5 x ULN;

8. 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.

9). Life expectancy ?3 months. 10). Voluntary participation in this study and voluntary signing of informed consent.

11). Men and women of gestational age must agree to use adequate contraception throughout the study and for 3 months after the end of treatment.

Exclusion Criteria:

• 1). 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).

2). Concomitant administration of modern Chinese medicinal preparations for antitumour and anti-tumour indications.

3). Patients who have received chemotherapy or anti-vascular endothelial growth factor receptor (VEGF) therapy.

4). Patients receiving systemic chemotherapy, hormonal therapy, immunotherapy, approved proteins/antibodies or any experimental drugs or treatments (30 days) or radiotherapy (within 14 days).

5). 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.

7). 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.

9). 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.

10). Patients with uncontrolled epilepsy, history of central nervous system disease or psychiatric disorders, hypertension.

11). Active autoimmune disease requiring systemic therapy within the past 2 years.

12). Clinically significant ascites on physical examination that cannot be controlled medically.

13). Pregnant or breastfeeding female patients, or those unwilling to use contraception during the trial.

14). Known hypersensitivity to Icaritin, Bevacizumab and chemotherapeutic drug components.

15). 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.

16). Vulnerable populations, including those with mental illness, cognitive impairment, critically ill patients, illiteracy, etc.

17). Presence of other reasons that the investigator considers inappropriate for participation in this study.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective remission rate (ORR)	The proportion of patients whose tumour volume shrinks to a pre-specified value and who are able to maintain the minimum timeframe requirement is the sum of the proportions in complete and partial remission.	up to 5 years
Secondary	Overall survival (OS)	Time from start of trial to death (from any cause).	up to 5 years
Secondary	Disease Control Rate (DCR)	Number of cases in remission (PR+CR) and stable lesions (SD) after treatment as a percentage of evaluable cases.	up to 5 years
Secondary	Duration of ongoing remission (DOR)	The time from the start of the first assessment of the tumour as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.	up to 5 years
Secondary	TRAEs	Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0	up to 5 years
Secondary	Quality of life of the patients	Quality of life of the patients will be assessed by Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire liscenced from The Functional Assessment of Chronic Illness Therapy System ("FACIT System"). By using the Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores. The higher the score, the better the QOL.	up to 5 years