Not Yet RecruitingPhase 2

Clinical Study of Radiotherapy Combined With Camrelizumab and Apatinib in the Treatment of Liver Cancer Patients .

China46 participantsStarted 2024-10-20

Plain-language summary

Clinical study of radiotherapy combined with Camrelizumab and Apatinib in the treatment of liver cancer patients with VP4.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients volunteered to join this study and signed informed consent;
✓. ≥18 years old, both men and women;
✓. Patients with hepatocellular carcinoma diagnosed by CT/MRI;
✓. Clinical liver cancer in Barcelona is stage C with portal vein tumor thrombus (PVTT, VP4), which is not suitable for operation or local treatment, or progresses after operation and/or local treatment;
✓. For patients who have progressed after local treatment, local treatment (including but not limited to surgery, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) has been completed at least 4 weeks before the baseline imaging scan, and the toxic reactions caused by local treatment (except alopecia) must be restored to the rating of National Cancer Institute-General Terminology for Adverse Events (NCI-CTCAE v5.0).
✓. Never received any systematic treatment for HCC before;
✓. Except for tumor thrombus, the number of intrahepatic and extrahepatic lesions is ≤10;
✓. The diameter of extrahepatic lesions is ≤ 5 cm;

Exclusion criteria

✕. Known hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibreboard cell carcinoma; Have other active malignant tumors except HCC within 5 years or at the same time. Localized tumors that have been cured, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., can be included in the group;
✕. The tumor thrombus occupies all the portal vein lumen;
✕. Except for tumor thrombus, the number of intrahepatic and extrahepatic lesions is more than 10;
✕. The diameter of extrahepatic lesions is more than 5 cm;
✕. Patients who are ready to undergo or have previously received organ or allogeneic bone marrow transplantation;
✕. Moderate and severe ascites with clinical symptoms (except for those who only show a small amount of ascites on imaging but are not accompanied by clinical symptoms); Uncontrolled or moderate or above pleural effusion and pericardial effusion;
✕. Patients who have a history of gastrointestinal bleeding or have a clear tendency of gastrointestinal bleeding within 6 months before the start of the study and treatment, such as: bleeding-risk or severe esophageal and gastric varices, local active gastrointestinal ulcer lesions, and persistent fecal occult blood positive, can not be included in the group (if the fecal occult blood is positive in the baseline period, it can be rechecked, and if it is still positive after the recheck, it needs to undergo gastroduodenoscopy (EGD), and if the EGD indicates bleeding-risk esophageal and gastric varices, it can not be included).
✕. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study treatment;

What they're measuring

Overall survival

Timeframe: up to 3 years

Trial details

NCT IDNCT06632522

SponsorBeijing Tsinghua Chang Gung Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

Contact for this trial

Gong Li, M.A.

13366061906 lga02375@btch.edu.cn

View on ClinicalTrials.gov More Liver Cancer trials