Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Antibodies

Apatinib

Immunoglobulins

Liver Extracts

Protein Kinase Inhibitors

Enzyme Inhibitors

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

SHR-1210

Subjects receive Apatinib orally every day with a dose escalation

Subjects receive FOLFOX4 treatment every 2 weeks

FOLFOX4

Subjects receive GEMOX treatment every 2 weeks

GEMOX

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.

A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC

A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC)

The incidence and grade of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Time to Progression (TTP) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Overal Survial will be calculated based on Kaplan-Meier estimates

Jiangsu HengRui Medicine Co., Ltd.

Bevacizumab

Lenvatinib

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab

IBR900 cell injection: 4.0×10\^9 cells, D1,D3 of each cycle. Lenvatinib: body weight ≥ 60kg, 12mg/qd; body weight \< 60kg, 8mg/qd; administered continuously from D5 of the first cycle

IBR900 combined with Lenvatinib

IBR900 cell injection: 4.0×10\^9 cells, D1,D3 of each cycle. Bevacizumab:15mg/kg, D1 of each cycle.

IBR900 combined with Bevacizumab

Xiaodi Li

Jingbo Wang

This is an open-label, nonrandomized investigator-initiated clinical trial to evaluate the safety, tolerability, and efficacy of IBR900 cell injection in combination with Lenvatinib or bevacizumab in subjects with advanced primary liver cancer.

Two treatment groups are set up in this study. The first treatment group is IBR900 cell injection combined with Lenvatinib. The second treatment group is IBR900 cell injection combined with bevacizumab. Each cycle of the two treatment groups is 21 days. After 4 cycles of treatment, if the investigator judges that the subjects may benefit from continuing treatment, the subjects can continue to receive more cycles of treatment. 6 subjects are enrolled in each treatment group, and the group assignment of subjects is determined by the investigator.

For subjects who have previously received Lenvatinib, they will not be able to continue to receive Lenvatinib after entering the study, but can be treated in combination with bevacizumab. For subjects who have previously received bevacizumab, they will not be able to continue to receive bevacizumab after entering the study, but can be treated in combination with Lenvatinib.

IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Advanced Primary Liver Cancer

A Single-Arm, Open-Label Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Subjects With Advanced Primary Liver Cancer

Blood samples will be collected at specified time points to detect the cytokine (IL-1β, IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α) concentration

Blood samples will be collected at specified time points to analyze the lymphocyte subtypes (CD3, CD4, CD8, CD19, CD56)

The incidence and severity of adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and the correlation between adverse events and IBR900 cell injection.

The proportion of subjects with complete and partial tumor remissions after treatment

The time from the beginning of treatment to the onset of tumor progression or death from any cause

From the beginning of treatment to the time of death from any cause

Proportion of subjects with complete, partial response and stable disease

The rate of best of disease response recorded from the beginning of study treatment to disease progression, recurrence, or death.

Imbioray (Hangzhou) Biomedicine Co., Ltd.

Shandong Public Health Clinical Center

Oxaliplatin

the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin

the group treated with Systematic Chemotherapy including Oxaliplatin

Elemene

Shukui Qin

Yinying Lu

Da Zhao

Yonghui An

Yuxian Bai

Huaimin Liu

Xianglin Yuan

Tao Zhang

Baochen Wang

Wensheng Qiu

Jin Li

Clinical Trial of Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer

Patients with advanced primary liver cancer will be enrolled in the trial , then separated randomly into two group. One group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin , another group treated with Systematic Chemotherapy including Oxaliplatin. The purpose of the study is to evaluate the effect and safety of the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer

One group treated with the Elemene Injection/Elemene Oral Emulusion in Combination with Systematic Chemotherapy including Oxaliplatin , another group treated with Systematic Chemotherapy including Oxaliplatin.

Clinical Trial of Elemene in Combination With Oxaliplatinin the Treatment of Advanced Primary Liver Cancer

Clinical Trial of Elemene Injection/Elemene Oral Emulsion in Combination With Systematic Chemotherapy Including Oxaliplatin in the First -Line Treatment of Advanced Primary Liver Cancer

Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.

Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.

Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause

Overall survival.The time of patient from randomization to death caused by any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC	NCT03092895	Advanced Primar... Advanced Biliar...	SHR-1210 Apatinib FOLFOX4 GEMOX	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Advanced Primary Liver Cancer	NCT05411757	Advanced Primar...	IBR900 combined... IBR900 combined...	18 Years - 75 Years	Shandong Public Health Clinical Center
Clinical Trial of Elemene in Combination With Oxaliplatinin the Treatment of Advanced Primary Liver Cancer	NCT03166553	Advanced Primar...	Elemene	18 Years - 75 Years	BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Advanced Primary Liver Cancer	NCT05411757	Advanced Primar...	IBR900 combined... IBR900 combined...	18 Years - 75 Years	Shandong Public Health Clinical Center
A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC	NCT03092895	Advanced Primar... Advanced Biliar...	SHR-1210 Apatinib FOLFOX4 GEMOX	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for advanced primary liver cancer