Clinical trial · Interventional
Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant
A Single Group, Open Label, Multi-center Clinical Study of Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of Hepatocellular Cancer Before Liver Transplant
NCT04035876CI-TRIAL-00039761unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab plus apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab plus apatinib
- interventionNames
- Drug: Camrelizumab plus apatinib
Primary outcomes (2)
- measure
- Objective remission rate
- timeFrame
- From enrollment to disease progression, up to 6 months
- description
- The proportion of patients with CR, PR, and SD in the group
- measure
- Recurrence-free survival
- timeFrame
- 1 year
- description
- The period from enrollment surgery to recurrence of HCC
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18-75 years * Pathology: hepatocellular carcinoma * Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor \>8 cm, but 100 ng/mL \< AFP \<400 ng/mL) * No interventional therapy (TACE, RFA or I131) within 2 month * Expected survival for more than 3 months * Child-pugh grade A or grade B (≤ 7 points) * Absolute neutrophil count ≥ 1.5×10\^9 /L, Hb ≥ 9 g/L, PLT ≥ 100×10\^9 /L; TSH ≤ ULN; total bilirubin ≤ 1.5 ULN, albumin ≥ 28 g/L, AST, ALT ≤ 3 ULN; serum creatinine ≤ 1.5 ULN * ECOG: 0-2 * Patients participate in the study voluntarily and sign informed consent Exclusion Criteria: * Regional lymph node metastases or extrahepatic metastases * Allergic to Camrelizumab or Apatinib * Patients who have had or are currently complicated with other malignant tumors * Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive) * Activ pulmonary tuberculosis or pulmonary tuberculosis history * Active, diagnosed, or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma) * Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy * Long-term systemic hormone therapy (dose \> 10mg prednisone/day) or any other form of immunosuppressive therapy * Myocardial ischemia or myocardial infarction above grade II, hypertension and inability to reach the normal range after medication (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg) * Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L); history of gastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoing thrombolytic or anticoagulant treatment * Pregnant or lactating women * Patients who participated in other clinical trials within 1 month * Active infections which require systemic treatment * HIV positive * Other factors that may affect patients' safety or compliance
References
Publications (0)
Data not yet available
No reference posted for this study.