Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

NCT06341296 | Recruiting Phase 2

• 1 other identifier: CSPC-DEY-CRC-K07
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  To investigate antitumor efficacy of study.

  From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months

Secondary Outcomes (6)

• Disease control rate

  From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first. Assessed up to 4 months

• Progression free survival

  From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 30 months.

• Overall survival

  From initial medication to the date of death from any cause. Assessed up to 30 months.

• Percentage of patients undergoing surgery.

  From the first dose to completed 8 cycles treatment. Assessed up to 5 months.

• R0 resection

  From the first dose to the surgery. Assessed up to 6 months.

Study Arms (1)

irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

EXPERIMENTAL

Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.

Drug: Irinotecan Liposome; Drug: 5-FU; Drug: LV; Drug: Bevacizumab

Interventions

Irinotecan Liposome DRUG

70 mg/m\^2 , d1, 14 days per cycle, 8 cycles.

irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

5-FU DRUG

5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.

irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

LV DRUG

400mg/m\^2, d1, 14 days per cycle, 8 cycles.

irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

Bevacizumab DRUG

5mg/kg, d1, 14 days per cycle, 8 cycles.

irinotecan liposome injection combined with 5-FU/LV+ bevacizumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~85 years old.
• Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma.
• RAS/BRAF v600e mutant or right half colon cancer is known.
• pMMR/MSS is known.
• The unresectable stage of metastatic disease has not received any systemic antitumor therapy.
• For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 6 months removed from the date of last administration of neoadjuvant or adjuvant therapy.
• ECOG 0\~1, patients ≥75 years old need an ECOG score of 0
• The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria.
• Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10\^9/L, platelets (PLT) ≥100×10\^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10\^9/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40 ml/min (calculated according to Cockroft-Gault)
• Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form.

You may not qualify if:

• Known or suspected central nervous system metastasis.
• Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
• Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment.
• Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 I or below(except hair loss and peripheral neuropathy).
• The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment.
• Severe gastrointestinal dysfunction, gastrointestinal perforation, intraperitoneal abscess, and fistula.
• Intestinal obstruction, signs and symptoms of intestinal obstruction, or the stent has been previously implanted and the stent has not been removed before the screening period.
• Interstitial lung disease.
• Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding).
• Patients with fluid accumulation that couldn't reach a stable state but small amount of ascites on imaging without clinical symptoms could be enrolled.
• Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc.
• Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer.
• Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding.
• The researchers didn't consider it appropriate to participate in this study.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital，Sichuan University

Sichuan, Sichuan, Chengdu, 610000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

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

Central Study Contacts

Meng Qiu, MD

CONTACT

028-85423203; qiumeng33@hotmail.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: Dr.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: June 30, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

CN (1)