Phase II Study of Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy for Patients with Locally Advanced Colorectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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 multiple primary colorectal cancer are eligible, if one of the primary tumors meets the inclusion criteria.

• 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.

‣ Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min.

‣ Total serum bilirubin ≤1.5 upper normal limit (ULN).

‣ Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 upper limit of normal value (ULN).

⁃ Women with reproductive potential (\< 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.

Locations
Other Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Lin Yang
linyangcicams@126.com
13611267380
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 36
Treatments
Experimental: Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine
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.
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov