Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04547452
Other study ID # I-SBRT-HCC-001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2020
Est. completion date July 1, 2023

Study information

Verified date July 2020
Source West China Hospital
Contact Xin Wang, PhD/MD
Phone +86 28 85423609
Email wangxin213@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date July 1, 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Histologically confirmed hepatocellular carcinoma or diagnosed by American Association for the Study of Liver Disease criteria;

2. Deemed ineligible for curative intent therapy with surgical resection or liver transplantation.

3. Estimated life expectancy =12 weeks;

4. Male or female subjects with age: 18-70 years old

5. Failure in first-line systemic treatment with sorafenib or Lenvatinib

6. Unwilling to receive or unable to tolerate first-line treatment with sorafenib

7. Have ECOG performance status 0-1

8. Have measurable disease based on RECIST 1.1.

9. Pretreatment CT chest /abdomen /pelvis within 28 days of protocol enrollment.

10. Child-Pugh class A liver function (assessed within 14 days of SBRT);

11. The function of important organs meets the following requirements: a. white blood cell count (WBC) = 3.0×109/L, absolute neutrophil count (ANC) = 1.5×109/L; b. platelets = 50×109/L; c. hemoglobin = 8g/dL; d. serum albumin = 3.0g/dL; e. total bilirubin = 2.0×ULN, ALT, AST = 5×ULN; f. serum creatinine = 1.5×ULN

12. Must have at least one lesion amenable to SBRT.

13. Ability to understand the study and sign informed consent.

Exclusion Criteria:

1. A history of abdominal radiotherapy;

2. Presence of active hepatitis B (HBV DNA = 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);

3. Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result)

4. History of organ transplantation or allogeneic bone marrow transplantation,or other acquired or congenital immunodeficiency diseases

5. Receipt of live, attenuated vaccine within 30 days prior to the study treatment

6. Has a known history of active TB (Bacillus Tuberculosis).

7. Uncontrolled intercurrent illness including, but not limited to digestive tract ulcer, uncontrolled hypertension, fracture, uncured wound, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

8. Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured

9. Female patients who are pregnant or lactating

10. Untreated central nervous system (CNS) metastatic disease, lepto-meningeal disease, or cord compression

11. Active infection requiring systemic therapy

12. Presence of clinically meaningful ascites,hydrothorax or hydropericardium and patients requiring non pharmacologic intervention (eg, paracentesis) or escalation in pharmacologic intervention to maintain symptomatic control

13. Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Stereotactic body radiation therapy
Sintilimab Combined with SBRT
Drug:
Anti-PD-1 antibody drug named Sintilimab
Sintilimab

Locations

Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24-week progression-free survival (PFS) ratev The proportion of patients with progression disease according to mRECIST at 24 weeks from randomization. 24 weeks after radiotherapy
Secondary Objective Response Rate (ORR) Investigator assessed ORR using RECIST v1.1 including the all tumor, the tumor undergoing LDRT and the tumor which do not receive radiotherapy. up to 24 months after the enrollment
Secondary Overall Survival (OS) OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause up to 24 months after the enrollment
Secondary 24-week disease control rate (DCR) The proportion of patients with complete response, partial response or stable disease according to mRECIST at 24 weeks from randomization. 24 weeks after radiotherapy
Secondary Duration of response (DOR) From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 24 months. up to 24 months after the enrollment
Secondary Adverse Events Treatment-related adverse events are graded according to the Common Toxicity Criteria, version 4.0, and were registered from the date of informed consent until discontinuation of trial treatment. 2 years from randomization
See also
  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 NCT03701607 - Effect of Chemotherapy on PD-L1 in NSCLC
Recruiting NCT03683407 - Effect of Chemotherapy on TMB 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