TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    34
  • sponsor
    Sun Yat-sen University
Updated on 3 October 2021
ct scan
cancer
TACE

Summary

The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with pd-1 antibody immunotherapy (Sintilimab) and anti-VEGF (Bevacizumab Biosimilar) in patients with advanced hepatocellular carcinoma (BCLC-C Stage).

Description

This is a prospective, single arm, phase II study to evaluate the efficacy and safety of TACE combined with Sintilimab and Bevacizumab Biosimilar (T-Double Therapy) in patients with HCC (BCLC-C Stage). Subjects who meet the admission criteria will be treated with Sintilimab and Bevacizumab Biosimilar after TACE until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued.

The primary outcome measure is to evaluate the objective response rate (ORR) of T-Double Therapy for advanced HCC (BCLC C-stage). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) in 6- and 12-months, overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS) of T-Double Therapy for advanced HCC. This study also aims to assess the safety and adverse reactions of T-Double Therapy for advanced HCC.

Details
Condition Adenocarcinoma, Liver Cancer, HEPATIC NEOPLASM, liver cell carcinoma, Malignant Adenoma, HEPATOCELLULAR CARCINOMA
Treatment Sintilimab; Bevacizumab Biosimilar
Clinical Study IdentifierNCT04796025
SponsorSun Yat-sen University
Last Modified on3 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patient voluntarily joined the study and signed an informed consent form
18 and 69 years old, both male and female
Clinically diagnosed or pathologically confirmed advanced hepatocellular carcinoma (unresectable or metastatic), at least one measurable focus without local treatment (according to mRECIST requirements, the measurable focus spiral CT scan length 10 mm or enlargement Short diameter of lymph node 15 mm)
Child-Pugh score 6 points (Child-Pugh A)
BCLC staging is stage C; PVTT classification is combined with PVTT (program classification PVTT 3), and a single lesion in the liver (or multiple lesions with diameter) 7cm of primary liver cancer
Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past
ECOG score: 01 (see Annex 1 for ECOG scoring criteria)
Expected survival period 12 weeks
The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration)
The absolute count of neutrophils1.5109/L; Platelet 80109/L; Hemoglobin 90 g/L; Serum albumin 28 g/L; Thyroid-stimulating hormone (TSH)1ULN (if abnormal, the levels of FT3 and FT4 should be examined at the same time, if the levels of FT3 and FT4 are normal, they can be included in the group); Bilirubin1.5ULN (within 7 days before the first administration); ALT and AST 3ULN (within 7 days before the first dose); AKP 2.5ULN; Serum creatinine1.5ULN
Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo surgical sterilization must be negative in serum or urine HCG within 72 hours before enrollment in the study; and must be non-lactating; for male patients whose partners are women of childbearing age, Carelil should be given during the trial and at the last time Use effective methods for contraception within 3 months after the onslumab

Exclusion Criteria

The patient has any active autoimmune disease or a history of autoimmune disease
The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment
The number of system treatment lines 2 lines
Severe allergic reaction to other monoclonal antibodies
Those with a known history of central nervous system metastasis or hepatic encephalopathy
Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past
Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those who have only a small amount of ascites on imaging but not accompanied by clinical symptoms
Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg)
Uncontrolled cardiac clinical symptoms or diseases, such as: NYHA level 2 or higher heart failure, unstable angina pectoris, myocardial infarction occurred within 1 year, clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention , QTc>450ms (male); QTc>470ms (female)
Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow the preventive use of low-dose aspirin and low molecular heparin
Significant clinically significant bleeding symptoms or clear bleeding tendency occurred within 3 months before randomization, such as pertussis/hemoptysis 2.5ml or more, gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, hemorrhagic stomach Ulcer or vasculitis, etc., if the stool occult blood is positive at the baseline, it can be re-examined. If it is still positive after the re-examination, a gastroscopy is required. If the gastroscope shows severe esophageal and gastric varices, it cannot be included in the group (3 before the group) Except those who have undergone gastroscopy within a month or less to exclude such cases)
Arterial/venous thrombosis events that occurred within 6 months before randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism
Known genetic or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.); Urine routine test showed urine protein ++ and confirmed 24-hour urine protein content> 1.0 g
Patients who have previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication; molecular targeted therapy (including other oral targeted drugs used in clinical trials) is less than the first study medication <5 drug half-lives, or patients whose adverse events (except alopecia) caused by previous treatment have not recovered to CTCAE level 1
The patient has active infection, fever of unknown origin within 7 days before medication 38.5, or baseline white blood cell count >15109/L; Patients with congenital or acquired immune deficiencies (such as HIV-infected persons)
Patients with HBV DNA>2000 IU/ml (or 104 copies/ml), HCV RNA>103 copies/ml, HBsAg+ and anti-HCV antibody positive
The patient suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
Patients with bone metastases who received palliative radiotherapy within 4 weeks before participating in the study >5% of the bone marrow area
The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or has previously received apatinib therapy
Live vaccine may be vaccinated less than 4 weeks before study medication or may be administered during the study period
According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests 22. Abnormalities, accompanied by family or social factors, will affect the safety of patients
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