Safety, Tolerability and Efficacy of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma,a Phase 1/2a Study
An open-label, multi-dose clinical trial design was used to investigate the combination of MB07133 injection combined with Sintilimab in the treatment of primary liver cancer in phase I/IIa studies, including two phases of dose escalation and dose expansion,in order to evaluate the safety and efficacy of MB07133 injection combined with Sintilimab.
• Age range from 18 to 70 years old (including 18 and 70 years old), regardless of gender;
• Non resectable hepatocellular carcinoma/mixed liver cancer confirmed by pathological diagnosis (pathological tissue/cytology) or clinical diagnosis (dynamic enhanced MRI/dynamic enhanced CT scan);
• At least one measurable lesion in the liver (in accordance with RECISIT1.1 standard);
• Child-Pugh liver function score: A/B (≤ 7 points);
• Expected survival time ≥ 12 weeks;
• ECOG score of 0 or 1;
• Patients who have completed chemotherapy/radiotherapy for tumors for more than 4 weeks (those who have received nitrosoureas and mitomycin chemotherapy for more than 6 weeks, those who have received small molecule targeted drugs (such as sorafenib and lovatinib) for more than 2 weeks), or those who have completed chemotherapy/radiotherapy for more than 5 half-lives (time limit whichever is longer), and those who have received the last intervention, radiotherapy, surgery, and ablation treatment for more than 4 weeks;
• Not using any anti-tumor drugs within 2 weeks before the first medication;
• Active hepatitis B patients should be controlled accordingly, and continue to take antiviral drugs and monitor liver function Can and hepatitis B virus load (such as: HBV DNA\<104 copies/ml (2000IU/ml)).
⁃ If the main organ function is normal, it meets the following standards: blood routine examination: HGB ≥ 90 g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L; Blood biochemical test: ALB ≥ 28 g/L; ALT and AST ≤ 5.0 × ULNTBIL ≤ 1.5 × ULN; Creatinine ≤ 1.5 × ULN; The electrolyte is normal or normal after treatment or judged by the researcher to be abnormal without clinical significance; Urinary routine examination: Urinary protein ≤ 1+, if urinary protein ≥ 2+but 24-hour urinary protein\<1.0g, it can be included in the group; ECG results: QTcB\<470ms for males and\<480ms for females; Thyroid function: Thyroid stimulating hormone (TSH) and free thyroxine (FT3) are within the normal range or have been determined by researchers to be abnormal without clinical significance.
⁃ Female patients of childbearing age or male patients with sexual partners of childbearing age should take effective contraceptive measures throughout the entire treatment period and 6 months after the last medication; Women of childbearing age cannot be in pregnancy or lactation.
⁃ The patient voluntarily signs a written informed consent form and is able to comply with the visit and related procedures stipulated in the plan.