A Clinical Study of Safety and Efficacy of T3011 Administered Via Intraperitoneal Injection as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intraperitoneal administration of T3011 at different doses in the treatment of malignant ascites induced by advanced colorectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female age ≥ 18 years and ≤ 75 years at the time of informed consent.

• Histologically or cytologically confirmed advanced unresectable or metastatic colorectal cancer;

• Anticipated life expectancy ≥3 months

• Associated with medium amount of malignant ascites (defined as the amount of ascites ≥3cm by B ultrasonography in lying position accompanied by clinical symptomes like abdonimal distension and cytology tests possitive for tumor in ascites); No paracentesis performed with 28 days before first dosing; and the ascites can not be controlled by SOC according to PI judgement.

• ECOG performance status 0-2 (including threshold);

• Weight ≥40kg

• Hematology:

‣ White blood cell (WBC) ≥ 3.0×10\^9/L;

⁃ Neutrophil (ANC) ≥ 1.5×10\^9/L;

⁃ Platelet (PLT) ≥ 75×10\^9/L;

⁃ Hemoglobin (Hb) ≥ 8.0g/dL

• Hepatic and renal function:

‣ Total bilirubin ≤ 1.5 × ULN;

⁃ Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN for patient without liver metastasis, ≤ 5 × ULN for patients with liver metastasis;

⁃ Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation;

⁃ Abumin≥30 g/L

• Coagulation:

‣ INR≤1.5 x ULN;

⁃ APTT≤1.5 x ULN;

⁃ For women of childbearing potential (WCBP), serum pregnancy test should be negative within 14 days before dosing. WCBP patients, as well as male patients with partners of WCBP, should consent to use at least one medically approved contraceptive method (e.g. surgical sterilization, oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) during the study and for at least 6 months after the last dosing;

⁃ Willingness to attend this study, to sign informed consent, to have good compliance, and to cooperate with follow-up visit.

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Meng Qiu, MD
qiumeng33@hotmail.com
028-85423203
Time Frame
Start Date: 2023-09-28
Estimated Completion Date: 2024-12
Participants
Target number of participants: 10
Treatments
Experimental: T3011
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov