Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Camrelizumab and Apatinib after Cryoablation

Cryoablation

Drug: Camrelizumab and Apatinib Camrelizumab (200mg), iv, Q3W; Apatinib (250mg), po, QD

Camrelizumab; Apatinib

Fei Gao, M.D.

Zhenkang Qiu, M.D.

Fei Gao, PhD, MD

Zhenakng Qiu, MD

The purpose of this study is to evaluate the efficacy and safety of cryoablation combined with pd-1 antibody immunotherapy (Camrelizumab) and anti-angiogenesis therapy (Apatinib) in patients with advanced hepatocellular carcinoma (HCC).

This is a prospective, single arm, phase 2 study to evaluate the efficacy and safety of cryoablation combined with Camrelizumab and Apatinib (C-couple Therapy) in patients with advanced HCC. Subjects who meet the admission criteria will be treated with Camrelizumab and Apatinib after cryoablation until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued.

The primary outcome measure is to evaluate the objective response rate (ORR) of C-couple Therapy for advanced HCC (BCLC C-stage). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) in 6- and 12-months, overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS) of C-couple Therapy for advanced HCC. This study also aims to assess the safety and adverse reactions of C-couple Therapy for advanced HCC.

Cryoablation Combined With Camrelizumab and Apatinib in Advanced Hepatocellular Carcinoma

Cryoablation Combined With Camrelizumab and Apatinib

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST.

DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST

The progression-free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST.

OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

Sun Yat-sen University

Chief physician

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Etoposide

Carboplatin

Etoposide phosphate

Extensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less.

Extensive SCLC patients who are central type or tumor vascular invasion grade two to three.

2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib

Camrelizumab; apatinib; carboplatin; etoposide

Chengzhi Zhou, MD

Ming Liu, MD

Xin Chen, MD

The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.

Camrelizumab is a humanized PD-1 monoclonal antibody. Camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. Median OS is 8.4 months. In our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.

We divide them into two cohorts based on the extent of tumor invasion to the mediastinum or hilar large vessels

Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC

Clinical Study of Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of Extensive Stage Small Cell Lung Cancer

Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cryoablation Combined With Camrelizumab and Apatinib in Advanced Hepatocellular Carcinoma	NCT04724226	Hepatocellular ...	Camrelizumab; A...	18 Years - 70 Years	Sun Yat-sen University
Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC	NCT05001412	Extensive Stage...	Camrelizumab; a...	18 Years - 75 Years	Guangzhou Institute of Respiratory Disease

Spots Global Cancer Trial Database for camrelizumab; apatinib