Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

NCT06184698 | Recruiting Phase 2 DMC

• 1 other identifier: CSPC-DEY-CRC-K04
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.

Conditions

Colorectal Cancer

Keywords

liposomal irinotecan; second-line therapy; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.

  4 months

Secondary Outcomes (5)

• Disease Control Rate

  4 months

• Duration of Response

  4 months

• Progress-free survival

  6 months

• Overall survival

  1 year

• Incidence of adverse events

  5 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

liposomal irinotecan+5-FU/LV+ bevacizumab q2w

Drug: liposomal irinotecan; Drug: 5-FU; Drug: LV; Drug: Bevacizumab

Interventions

liposomal irinotecan DRUG

liposomal irinotecan 70 mg/m²

Also known as: nal-IRI

Experimental Group

5-FU DRUG

5-FU 2400 mg/m²

Also known as: Fluorouracil

Experimental Group

LV DRUG

5-FU 2400 mg/m²

Also known as: Calcium folinate

Experimental Group

Bevacizumab DRUG

bevacizumab 5 mg/kg

Also known as: Avastin

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old.
• Histologically or cytologically proven colon or rectum adenocarcinoma.
• Confirmed as unresectable metastatic disease through radiological examination.
• At least one measurable lesion (according to RECIST v1.1).
• First-line treatment with oxaliplatin-based therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 2.
• 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, white blood cell (WBC)≥3.0×10\^9/L.
• Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present.
• Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL/min, proteinuria \<2+.
• Normal coagulation function (INR≤1.5).
• 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 prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
• Previous treatment with irinotecan/liposomal irinotecan.
• MSI-H/dMMR
• Massive pleural effusion or ascites requiring intervention.
• Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
• Active HIV, HBV, HCV infection.
• Combined with uncontrollable systemic diseases.
• Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction , \> grade 1 diarrhea or gastrointestinal perforation)
• History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrolment.
• Presence of interstitial pneumonia or pulmonary fibrosis.
• Allergy to or intolerance to therapeutic drugs or their excipients;.
• History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within one month prior to enrollment.
• Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before enrollment.
• Patients with symptomatic central nervous system metastases.
• Documented serum albumin ≤3 g/dL

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

irinotecan sucrosofate; Fluorouracil; Leucovorin; 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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Guiying Wang, Professor

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuhua Hu, Doctor

CONTACT

0311-86095347; huxvhua@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 28, 2023
• Study Start: January 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)