Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer

NCT06405139 | Recruiting Phase 2

• 1 other identifier: NCC4610
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer, esophageal cancer, gastric cancer, and rectal cancer. However, the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage. The objective of this study is to explore the efficacy and safety of nanoliposomal irinotecan and oxaliplatin combined with capecitabine as a novel conversion therapy for locally advanced colorectal cancer patients.

Conditions

Colorectal Cancer

Keywords

Locally Advanced Colorectal Cancer; Nanoliposomal Irinotecan; Oxaliplatin; Capecitabine; Conversion Therapy

Outcome Measures

Primary Outcomes (1)

• Organ-sparing R0 Resection Rate

  The proportion of patients achieved R0 resection by only resecting the colon while other organs were retained.

  2 years

Secondary Outcomes (7)

• ypTNM stage

  2 years

• TRG

  2 years

• R0, R1, R2 resection rate

  2 years

• Rate of residual or recurrent disease occurring within 2 years after surgery

  2 years

• 3-year OS rate

  3 years

Study Arms (1)

Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine

EXPERIMENTAL

Patients will receive a modified FOLFOXIRI regimen (nanoliposomal irinotecan 60mg/m2, oxaliplatin 85 mg/m2, and capecitabine 800 mg/m2 twice daily, day 1 to 7), repeated every two weeks. The efficacy and resectability were evaluated every four cycles. Patients who had lesions that were radically resectable after evaluation will receive surgery. This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles.

Drug: Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine

Interventions

Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine DRUG

Nanoliposomal irinotecan 60mg/m2; Oxaliplatin 85 mg/m2; Capecitabine 800 mg/m2 twice daily, day 1 to 7; repeated every two weeks.

Also known as: Nanoliposomal Irinotecan, Oxaliplatin, Capecitabine

Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With a full understanding of the study, each participant volunteered to participate in this study and signed the informed consent (ICF) with good compliance and follow-up.
• Age ≥18 and ≤70.
• ECOG physical status score is 0 or 1.
• Expected survival period ≥ 12 weeks.
• Patients with histopathological confirmed MSS/pMMR-type adenocarcinoma of the colon and upper rectum which is not amenable to radiotherapy.
• R0 resection was expected to be achieved by necessarily combined organ resection, or R0 resection cannot be achieved, assessed by CT and/or MRI and multidisciplinary team (MDT) discussion.
• The clinical stage was cT4N1-2M0 or cT4bN0M0 according to AJCC 8th edition.
• Patients with intestinal obstruction was relieved by colonic stenting or ostomy.
• Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• At least one evaluable lesion (according to RECIST v1.1 standard);
• Adequate organ function according to the following laboratory test values:
• Hemoglobin value ≥90g/L.
• White blood cell count ≥3.5\*109/L.
• Absolute neutrophil count ≥1.5\*109/L.
• Platelet count ≥100\*109/L.

You may not qualify if:

• Patients who had shown hypersensitivity to the test drugs or other liposomal products.
• Patients who have participated in other clinical trials in the past 4 weeks.
• Previous or concurrent cancer diagnosed within 5 years (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 5 years, and there is no clinical and imaging evidence of recurrence or progression except).
• dMMR/MSI-H-type colorectal cancer.
• Symptomatic peripheral neuropathy ≥ grade 2 (CTCAE 5.0).
• Patients unable to swallow or lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
• Patients had severe bleeding (CTCAE 5.0 grade ≥3) in the previous 4 weeks.
• History of abdominal fistula, gastrointestinal perforation, intestinal obstruction, chronic diarrhea, or inflammatory bowel disease including Crohn's disease and ulcerative colitis within 6 months prior to the first study treatment.
• Patients with interstitial lung disease, except only imaging demonstrated interstitial lung disease without symptoms.
• Uncontrolled central nervous system metastasis (symptomatic or metastatic sites are midbrain, pons, medulla, or spinal cord) or other central nervous system diseases.
• Received strong inhibitors or inducers of CYP3A4 and CYP2C8, or strong inhibitors of UGT1A1 in the previous 2 weeks.
• Uncontrolled hypertension by a single-antihypertensive medication (systolic blood pressure \>140 mmHg or diastolic pressure \>90 mmHg). Patients with severe cardiac dysfunction, such as LVEF\< 50%, CHF≥ grade 2, severe/unstable angina, history of stroke or transient ischemic attack or myocardial infarction in the previous 6 months. Patients with a history of ventricular tachycardia, torsades de pointes, prolonged QTc, complete left bundle branch block, or third-degree atrioventricular conduction block.
• Abnormal blood coagulation function, bleeding tendency or receiving thrombolysis or anticoagulant therapy.
• Patients of childbearing potential are unwilling to practice contraception.
• Patients with active hepatitis B, hepatitis C, syphilis, or human immunodeficiency virus infection.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

irinotecan sucrosofate; Oxaliplatin; Capecitabine

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)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lin Yang

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yang

CONTACT

13611267380; linyangcicams@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: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-05

Locations

CN (1)