Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC

Conditions

• Colorectal Neoplasms Malignant

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Irinotecan liposome (ll) + 5-FU/LV + bevacizumab — DRUG
  1. Bevacizumab: 5 mg/kg, d1, q2w; 2. Irinotecan Hydrochloride Liposomal Injection (II): 60 mg/m2, d1, q2w; 3. leucovorin: 400 mg/m2, d1, q2w; 4. 5-fluorouracil: 2800 mg/m2, d1, q2w.

Study Details

To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.

Key Dates

Start date

Nov 4, 2024

Status verified

Sep 2024

Primary completion

Oct 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Irinotecan liposome (Ⅱ) combined with 5-fluorouracil, leucovorin, and bevacizumab
  Irinotecan liposome (Ⅱ) + 5-FU/LV + bevacizumab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 2 months after patient administration ]

Central Contacts

• Xiancheng X Liu, Master
  15206295168
  [email protected]
• Hongmei H Gu

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