A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Asci… (NCT06200376) | Clinical Trial Compass
UnknownPhase 1
A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer
China10 participantsStarted 2023-09-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Hepatic and renal function:
Exclusion criteria
✕. Previously diagnosed with decompensated cirrhosis, and with portal vein and branch involvement or cancer embolus;
✕. Pregnant or lactating, or plan to pregnant or give birth during the trial;
✕. Persistent or active infection that are not controlled by treatment including but not limited to: active tuberculosis, non-negative HIV antibody, HBsAg positive and HBV DNA ≥LOQ, HCV ab positive and HCV DNA ≥LOQ;
. Patients with imageological confirmed brain metastasis or brain metastasis history (except patients with stable disease within 3 months before screening and not require systemic glucorticoid therapy according to PI), pia meningeal disease, spinal cord compression;
✕. Autoimmune disease or related symptoms, or previously suffered from autoimmune disease;
✕. History of splenectomy or organ transplantation;
✕. Prior treatment with Oncolytic virus (OV) (including but not be limited to T-VEC, T3011), gene therapy, cellular therapy or tumor vaccines;
✕. Requires oral or intravenous therapy against herpes virus (including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Topical use of drugs (eg. external use) are allowed;