A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With … (NCT03764293) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
United States543 participantsStarted 2019-06-10
Plain-language summary
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histopathologically or cytologically confirmed advanced HCC
* No previous systematic treatment for HCC
* Have at least one measurable lesion (in accordance with RECIST v1.1)
* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
* ECOG-PS score 0 or 1
* Child-Pugh Class: Grade A
* Life Expectancy of at least 12 weeks
* Subjects with HBV infection: HBV DNA\<500 IU/ml or \< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
* Subjects with HCV-RNA(+) must receive antiviral therapy
* Adequate organ function
Exclusion Criteria:
* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
* Moderate-to-severe ascites with clinical symptoms
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Cardiac clinical symptom or disease that is not well controlled
* Hypertension that can not be well controlled through antihypertensive drugs
* Factors to affect ora…
What they're measuring
1
Overall Survival (OS)
Timeframe: Up to approximately 3 years
2
Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1