Hepatocellular Cancer
Conditions
Keywords
hepatocellular cancer
Brief summary
The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
Interventions
DRUGSHR-1826
SHR-1826 will be administrated per dose level in which the patients are assigned.
DRUGSHR-1826 and immunotherapy combination therapy
SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.18-75 years old, male or female. 2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery; 3.Failure of at least one line of standard treatment (progression or intolerance); 4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion); 5.Expected survival time ≥ 12 weeks; 6.Normal function of major organs; 7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.
Exclusion criteria
1. Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type); 2. Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.; 3. Have central nervous system metastasis; 4. Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation); 5. Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study; 6. Other situations in which the investigator deems that the subject should not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) by RECIST V1.1 | up 2 years | The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) by mRECIST | up 2 years | The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST. |
| Disease control rate (DCR) by RECIST V1.1 | up 2 years | The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD). |
| Progression-free survival (PFS) | up 2 years | The PFS is defined as Time from the date of enrollment to of disease. |
| Overall survival (OS) | up 2 years | The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. |
Countries
China
Contacts
Primary ContactGuoming Shi, M.D
Outcome results
None listed