Combining radiation therapy with immunotherapy and targeted therapy for liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial aims to evaluate the effectiveness and safety of combining stereotactic body radiation therapy (SBRT) with the immunotherapy drug tislelizumab and the targeted therapy regorafenib in patients suffering from unresectable or oligometastatic hepatocellular carcinoma (HCC). Participants will receive SBRT targeting all visible lesions while concurrently undergoing systemic treatment with the two therapies. The primary objective is to determine if this combination can prolong progression-free survival (PFS) in these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age ≥ 18 years
* Eastern Cooperative Oncology Group performance status of 0-1
* clinical or pathological diagnosis of HCC
* with unresectable locally advanced or oligometastatic HCC (metastatic lesions ≤ 5, metastatic organs ≤ 3, may involve extrahepatic lymph nodes or distant organs apart from brain)
* at least one measurable lesion according to mRECIST criteria
* all lesions could be included in radiation target volume
* Child-Pugh A or B (7 scores) liver function
* patients are allowed to receive systemic therapy previously other than tislelizumab plus regorafenib
* adequate hematological and renal function
* life expectancy ≥ 3 months；
* willing to participate in the study and give written informed consent

Exclusion Criteria:

* a history of liver transplantation
* with severe cirrhosis complications, including a history of esophagogastric variceal bleeding, hepatic encephalopathy, and massive ascites
* with active autoimmune diseases or a history of autoimmune disease
* with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
* allergic to the ingredient of tislelizumab or regorafenib
* with recurrent lesions treated with radiotherapy previously
* prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR)
* intolerable to radiation or systemic treatment because of cardiac insufficiency, uncontrolled high blood pressure
* a history of other malignancies, except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

  This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.

  Recruiting Phase 3 CSPC Megalith Biopharmaceutical Co.,Ltd. · Guangzhou, Guangzhou · NCT07925021

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Tislelizumab plus Anlotinib after chemoradiotherapy in limited-stage SCLC

  This phase II trial tests whether adding tislelizumab and anlotinib after chemoradiotherapy helps people with limited-stage small cell lung cancer stay cancer-free.

  Recruiting Phase 2 Yantai Yuhuangding Hospital · Yantai, Shandong · NCT07815223

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

  This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.

  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• First-line combo therapy with anlotinib, benmelstobart, and HAIC for unresectable HCC

  This study tests whether adding benmelstobart and hepatic arterial infusion chemotherapy to anlotinib can help people with unresectable hepatocellular carcinoma respond to treatment as a first line.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07806292

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.