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

NCT06632522 | Not Yet Recruiting Phase 2

• 1 other identifier: 24250-4-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cancer

Keywords

Combined with portal vein tumor thrombus,VP4

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The time from the beginning of treatment to the progression of the disease or death from any cause.

  up to 3 years

Secondary Outcomes (3)

• Progression-free survival

  up to 3 years

• Objective response rate

  up to 3 years

• Disease control rate

  up to 3 years

Study Arms (1)

radiotherapy combined with Camrelizumab and Apatinib

EXPERIMENTAL

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

Drug: radiotherapy combined with Camrelizumab and Apatinib

Interventions

radiotherapy combined with Camrelizumab and Apatinib DRUG

Camrelizumab is administered intravenously (without preventive medication), with a fixed dose of 200mg, with an infusion of 30 min (not less than 20 min and not more than 60 min) every three weeks. Apatinib, 250 mg, taken orally within half an hour after meals, QD, continuously.

radiotherapy combined with Camrelizumab and Apatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• At least one measurable lesion (according to the requirements of RECISTv1.1, the long diameter of the measurable lesion in spiral CT scanning is ≥10 mm or the short diameter of swollen lymph nodes is ≥15 mm; Lesions that have received local treatment in the past (except radiotherapy for target lesions) can be used as target lesions after they are clearly advanced according to RECIST v1.1 standard);
• Child-Pugh liver function classification is Grade A or Grade B (score ≤7).
• ECOG score: 0 \~ 1;
• The expected survival time is ≥12 weeks;
• The main organ functions meet the following requirements (within 7 days before the start of the study and treatment):
• (1) Routine blood examination: (Except hemoglobin, no blood transfusion, no use of granulocyte colony stimulating factor \[G-CSF\] and no drug correction within 14 days before screening): Absolute neutrophil count ≥1.5×109/L; Platelets ≥50×109/L; Hb ≥90 g/L; (2) Biochemical examination: (albumin was not transfused within 14 days before screening): Serum albumin ≥29 g/L; Serum total bilirubin ≤1.5× upper limit of normal range (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase acidase (AKP)≤5×ULN; Serum creatinine (Cr)≤1.5ULN or Cr clearance rate \> 50 mL/min (Cockcroft-Gault formula is as follows).
• Male: Cr clearance rate =((140- age) × body weight) /(72× blood Cr) Female: Cr clearance rate =((140- age )× body weight) /(72× blood Cr) × 0.85 body weight unit: kg; Blood Cr unit: mg/mL; (3) The international normalized ratio (INR) is ≤ 2.3 or the prothrombin time (PT) exceeds the range of normal control for ≤6 seconds; (4) Urinary protein \< 2+ (if urinary protein ≥2+, 24-hour (h) urinary protein quantification can be performed, and 24-hour urinary protein quantification \< 1.0 g can be enrolled).

You may not qualify if:

• 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;
• Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients; At present, or in the near future (within 10 days before the start of the study treatment), full-dose oral or injection anticoagulants or thrombolytic drugs have been used for therapeutic purposes (low-dose aspirin and low-molecular-weight heparin are allowed for preventive use);
• Aspirin (\> 325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol are currently being used or recently used (within 10 days before the start of the study treatment);
• Thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) and pulmonary embolism;
• There are clinical symptoms or diseases of the heart that can't be well controlled, such as: (1) according to the standards of new york Heart Association (NYHA) (see Annex 5), the cardiac insufficiency is above grade 5)II or the left ventricular ejection fraction (LVEF) is less than 50%; (2) Unstable angina pectoris; (3) myocardial infarction occurred within one year before the start of study and treatment; (4) Clinically significant supraventricular or ventricular arrhythmia needs treatment or intervention; (5)QTc \> 450ms (male); QTc \> 470ms (female) (QTc interval is calculated by Fridericia formula; If the QTc is abnormal, it can be continuously tested for three times every 2 minutes, and the average value can be taken);
• Suffering from high blood pressure, which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) (based on the average of BP readings obtained by ≥2 measurements), it is allowed to realize the above parameters by using antihypertensive therapy; Hypertensive crisis or hypertensive encephalopathy has occurred in the past;
• Major vascular diseases (for example, aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) occurred within 6 months before the start of study treatment;
• Severe, unhealed or split wounds and active ulcers or untreated fractures;

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Gong Li, M.A.

  Tsinghua Chang Gung Hospital

  STUDY DIRECTOR

Central Study Contacts

Gong Li, M.A.

CONTACT

13366061906; lga02375@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 9, 2024
• Study Start: October 20, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CN (1)