Immunotherapy Clinical Trial
Official title:
Combination of Sintilimab and Stereotactic Body Radiotherapy in Advanced Metastatic Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is a common malignancy, and more than 70% of newly diagnosed
HCC patients already have advanced disease. Sorafenib and lenvatinib are recommended as
first-line options for advanced HCC. The PD-1 monoclonal antibody，such as nivolumab and
pembrolizumab, have been approved to treat the patients with advanced HCC by the FDA.
Combining radiotherapy with immune checkpoints showed promising response rates and improved
survival in several solid tumor types. The purpose of this randomized study is to determine
whether stereotactic body radiation therapy (SBRT) combined with sintilimab (an anti-PD-1
antibody) will improve the response to the anticancer treatment compared to sintilimab alone
in patients with advanced HCC.
About 84 participants will be enrolled in this study. All will take part at West China
Hospital, Sichuan University.
A total of 84 HCC patients who are failure from the first line Sorafenib or lenvatinib
treatment will be randomized to two treatment arms using a 1:1 ratio: SBRT + PD-1 arm or PD-1
alone arm.
Patients in both arms will receive sintilimab administered intravenously at 200 mg every 3
weeks. Stereotactic body radiotherapy (SBRT) using volumetric arc therapy. The prescribed
dose is 30-54 Gy in 3-6 fractions over 1-2 weeks. In the SBRT + PD-1 arm, sintilimab is
administered intravenously at 200 mg every 3 weeks for up to 1 year. The first course of
sintilimab will be given within 4-6 weeks after completion of SBRT.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05848011 -
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05161572 -
Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer
|
Phase 2 | |
| Recruiting |
NCT06165900 -
Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
|
Phase 2 | |
| Recruiting |
NCT06120127 -
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
|
Phase 2 | |
| Recruiting |
NCT06262581 -
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
|
Phase 2 | |
| Recruiting |
NCT05176002 -
Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05909137 -
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
|
||
| Recruiting |
NCT04500990 -
MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
|
||
| Not yet recruiting |
NCT04372732 -
Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
|
||
| Completed |
NCT02692976 -
Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 2 | |
| Completed |
NCT03763630 -
MAPS & ITEC Cohorts: 6-8 Years Follow-up
|
Phase 2 | |
| Not yet recruiting |
NCT06012318 -
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
|
||
| Not yet recruiting |
NCT05479240 -
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
|
Phase 2 | |
| Recruiting |
NCT04711330 -
Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
|
||
| Recruiting |
NCT05515796 -
Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors
|
Phase 2 | |
| Recruiting |
NCT03683407 -
Effect of Chemotherapy on TMB in NSCLC
|
||
| Recruiting |
NCT03701607 -
Effect of Chemotherapy on PD-L1 in NSCLC
|
||
| Completed |
NCT03357861 -
Cancer Patients Treated With Immunotherapy in Intensive Care Unit
|
||
| Recruiting |
NCT05223088 -
Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer
|
Phase 2 | |
| Completed |
NCT05657262 -
Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas
|
N/A |