Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer

NCT06192680 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CSPC-DEY-CRC-K05
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

This multicenter, single-arm trial will explore the efficacy and safety of liposomal irinotecan and capecitabine plus bevacizumab as second-line therapy in metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

metastatic disease; liposomal irinotecan; second-line therapy

Outcome Measures

Primary Outcomes (1)

• Progression free Survival

  Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.

  1 year

Secondary Outcomes (5)

• Objective Response Rate

  6 months

• Disease Control Rate

  6 months

• Duration of Response

  6 months

• Overall survival

  2 years

• Incidence of adverse events

  7 months

Study Arms (1)

liposomal irinotecan + capecitabine + bevacizumab

EXPERIMENTAL

liposomal irinotecan 70 mg/m², d1 + capecitabine 1000 mg/m² BID, d1\~10 + bevacizumab 5mg/kg, d1. q2w

Drug: Liposomal irinotecan; Drug: Capecitabine; Drug: Bevacizumab

Interventions

Liposomal irinotecan DRUG

70 mg/m² IV

Also known as: nal-IRI

liposomal irinotecan + capecitabine + bevacizumab

Capecitabine DRUG

1000 mg/m² PO BID

Also known as: Xeloda

liposomal irinotecan + capecitabine + bevacizumab

Bevacizumab DRUG

5mg/kg IV

Also known as: Avastin

liposomal irinotecan + capecitabine + bevacizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years old.
• Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma, and patients failed or are intolerant to first-line treatment with oxaliplatin ± VEGF/EGFR.
• At least one measurable lesion (according to RECIST v1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
• The expected survival time ≥3 months.
• Subject has adequate biological parameters as demonstrated by the following: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count ≥100×10\^9/L, Hemoglobin (Hgb) ≥90 g/L.
• Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, ≤5 × ULN if liver metastases are present. Serum albumin ≥3 g/dL.
• Adequate renal function as evidenced by serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. Proteinuria \< 2+ (those with proteinuria ≥2+ at baseline had to demonstrate ≤1 g protein per 24 hours).
• Coagulation function: International normalised ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5 × ULN.
• Left ventricular ejection fraction (LVEF) ≥50%.
• Subjects agree to use contraception and are not pregnant or breastfeeding women.
• Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.

You may not qualify if:

• Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
• Previous treatment with irinotecan/liposomal irinotecan.
• Patients with the primary lesion located in the left colon and RAS/BRAF wild-type who did not use cetuximab on the first line.
• Known as high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
• Massive pleural effusion or ascites requiring intervention.
• Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
• Active HIV infection.
• Combined with uncontrollable systemic diseases within 6 months before the first administration.
• Presence of severe gastrointestinal disease.
• History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration, or plan to undergo major surgery during the study period.
• Presence of interstitial pneumonia or pulmonary fibrosis.
• History of allergy or hypersensitivity to drug or any of their excipients.
• History of pulmonary hemorrhage/hemoptysis ≥Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration.
• Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before the first administration.
• Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome.

Sponsors & Collaborators

• Harbin Medical University: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

irinotecan sucrosofate; Capecitabine; 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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yanqiao Zhang, Professor

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Su, Ms.

CONTACT

0451-86298278; 471018565@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: April 1, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share