Phase 2
Completed N=157
A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
Advanced Primary Liver Cancer · Advanced Biliary Tract Carcinoma
Source: ClinicalTrials.gov NCT03092895 ↗
Enrolled (actual)
157
Serious AEs
59.9%
Results posted
Jan 2026
Primary outcomePrimary: The Safety and Tolerability — 28; 34; 92; 3 participants
Summary
This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 or GEMOX regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety and Tolerability |
28; 34; 92; 3; 14; 20 | — |
| SECONDARY Objective Response Rate (ORR) |
10.7; 29.4; 16.3; 33.3 | — |
| SECONDARY Duration of Response (DoR) |
11.30; 7.10; 7.10; 7.20 | — |
| SECONDARY Disease Control Rate (DCR) |
64.3; 79.4; 75.0; 33.3 | — |
| SECONDARY Time to Progression (TTP) |
3.7; 5.7; 5.5; 2.0 | — |
| SECONDARY Overall Survival |
13.3; 11.7; 10.7; 17.6 | — |
| SECONDARY Time to Response (TTR) |
3.65; 1.99; 1.84; 1.87 | — |
| SECONDARY Progression-free Survival (PFS) |
3.7; 5.7; 5.3; 2.0 | — |
Eligibility Criteria
- Histologically confirmed advanced PLC or advanced BTC (including bile duct carcinoma and gallbladder carcinoma) ; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1.
- Arm A: Failed or intolerable to at least one prior systemic treatment for advanced PLC. Arm B:No previous systemic treatment for advanced PLC or BTC
- ECOG Performance Status of 0 or1.
- Child-Pugh Class A or B with 7 points .
- Life Expectancy of at least 12 weeks.
- Has controlled infection by Hepatitis B Virus (HBV DNA 140mmHg, diastolic blood pressure > 90 mmHg).
- Factors to affect oral administration (such as patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption).
- History of hepatic encephalopathy.
- Known history of human immunodeficiency virus (HIV) infection.
- Active infection or an unexplained fever > 38.5°C during screening visits.
- Has received a live vaccine within 30 days.
- Prior or planning to organ transplantation including liver transplantation.
- Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- Proteinuria≥ 2+ or 24 hours total urine protein > 1.0 g.
- Active known, or suspected autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily. prednisone equivalent, are permitted in the absence of active autoimmune disease
- Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.
- Prior therapy with anti-PD-1 or other anti-PD-1/anti-PD-L1 immunotherapy.
- Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.
- Treatment with anti-coagulation therapy(Warfarin or heparin) or anti-platelet therapy(aspirin at dose≥300mg/day, clopidogrel at dose≥75mg/day).
- Pregnant or breast-feeding women.
- According to the investigator, other conditions that may lead to stop the research.
Data sourced from ClinicalTrials.gov (NCT03092895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.