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Liver CancerPhase 2NCT06632522

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

A Phase 2 study testing radiotherapy combined with Camrelizumab and Apatinib in people with Liver Cancer, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer
What is being tested?
radiotherapy combined with Camrelizumab and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
20 Oct 2024to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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):
  • 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).
  • 14. If the patient suffers from active hepatitis B virus (HBV) infection, the HBV- deoxyribonucleic acid (DNA) must be less than 500 IU/mL (if the research center only has a copy/mL detection unit, it must be less than 2500 copy/mL), and he must receive anti-HBV treatment (according to local standard treatment, such as entecavir) for at least 14 days before the start of the research treatment, and he is willing to take the whole course during the research period. Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral treatment according to local standard treatment guidelines, and their liver function should be within the level 1 increase of CT CAE.
  • Fertile women: they must agree to abstain from sex (avoid heterosexual intercourse) or use reliable and effective methods of contraception for at least 120 days from signing the informed consent form until the last administration of the study drug. And the serum HCG test must be negative within 7 days before the start of the study treatment; And must be non-lactating. If a female patient has menstruated, has not yet reached the post-menopausal state (continuous non-menstrual period ≥12 months, and no other reasons have been found except menopause), and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation or bilateral oophorectomy), it is considered that the patient has fertility. For male patients whose partner is a woman of childbearing age, they must agree to abstain from sex for at least 120 days from signing the informed consent form until the last administration of the study drug, or to use reliable and effective methods for contraception. Male subjects must also agree not to donate sperm during the same period. Male subjects whose partners are pregnant must use condoms, and no other contraceptive methods are needed.

Who cannot join

  • 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;
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  • 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;
  • Received major surgical treatment (except diagnosis) within 4 weeks before the start of the study treatment or expected major surgical treatment during the study period;
  • Can't swallow pills, malabsorption syndrome or any condition that affects gastrointestinal absorption;
  • Have suffered from intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting the study and treatment, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition or tube feeding:
  • At the initial diagnosis, patients with incomplete obstruction/obstruction syndrome/signs/symptoms of intestinal obstruction may be enrolled in the study if they receive definite (surgical) treatment to relieve symptoms;
  • There is evidence that there is pneumoperitoneum that cannot be explained by puncture or recent surgical operation;
  • Past or present central nervous system metastasis;
  • Metastatic diseases involving major airways or blood vessels (for example, portal vein trunk or vena cava that is completely occluded due to tumor invasion needs to be excluded, portal vein trunk refers to the confluence of splenic vein and superior mesenteric vein and the branch where hepatic portal vein divides into left and right branches) or large mediastinal tumor mass in the center (< 30 mm from carina);
  • Those with a history of hepatic encephalopathy;
  • At present, patients with interstitial pneumonia or interstitial lung disease, or patients with previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other subjects with pulmonary fibrosis, organized pneumonia (for example, bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with evidence of active pneumonia or severe impairment of lung function on chest computed tomography (CT) during screening period are allowed to have radiation fields. Active tuberculosis;
  • Active autoimmune disease or history of autoimmune disease and possible recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can only be controlled by hormone replacement therapy can be included]); Subjects suffering from skin diseases without systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin or asthma in childhood have been completely relieved, and adults can be included without any intervention; Asthmatic patients who need bronchodilators for medical intervention cannot be included;
  • Use immunosuppressant or systemic hormone therapy within 14 days before starting the study treatment to achieve the purpose of immunosuppression (dosage > 10mg/ day of prednisone or other therapeutic hormones);
  • Strong CYP3A4/ CYP2C19 inducers used within 14 days before starting the study treatment include rifampicin (and its analogues) and Hypericum perforatum or strong CYP3A4/ CYP2C19 inhibitors;
  • It is known that there is a serious allergic history to any monoclonal antibody and anti-angiogenesis targeted drugs;
  • Severe infection within 4 weeks before the start of study treatment, including but not limited to hospitalization due to infection, bacteremia or complications of severe pneumonia; Therapeutic antibiotics were given orally or intravenously within 2 weeks before the start of the study treatment (patients receiving preventive antibiotics (for example, patients who prevent urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible to participate in the study); 30 patients with congenital or acquired immune deficiency (such as HIV infection);
  • 31. Co-infection with hepatitis B and hepatitis C; 32. Previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or previously received apatinib and sorafenib therapy; 33. Palliative radiotherapy for non-target lesions allowed to control symptoms must be completed at least 2 weeks before the start of the study treatment, and the adverse events caused by radiotherapy have not recovered to ≤ CTCAE level 1; 34. Received live attenuated vaccine treatment within 28 days before the start of the study treatment, or expected to be vaccinated during the treatment period of Karelizumab or within 60 days after the last dose of Karelizumab; 35. Have received other experimental drugs within 28 days before starting the study treatment; According to the researcher's judgment, the patient has other factors that may affect the research results or lead to the forced termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness) that need to be treated together, serious laboratory abnormalities, family or social factors, which will affect the safety of the patient.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gong Li, M.A. contact

13366061906

lga02375@btch.edu.cn

China1 site

  • Beijing Tsinghua Chang Gung Hospital

    Beijing, Beijing Municipality

    Gong Li, M.A., 13366061906, lga02375@btch.edu.cn

Other trials in China

About this study

Official title: Clinical Study of Radiotherapy Combined With Camrelizumab and Apatinib in the Treatment of Liver Cancer Patients With VP4.

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

Read the detailed description

This study is a single-arm, open, prospective and multi-center clinical study, aiming at observing and evaluating the efficacy and safety of radiotherapy combined with Camrelizumab and apatinib in the treatment of patients with VP4 liver cancer.

Conditions
Liver Cancer
Being tested
radiotherapy combined with Camrelizumab and Apatinib
Keywords
Combined with portal vein tumor thrombus,VP4
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiotherapy combined with Camrelizumab and ApatinibDrug

    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.

Study groups in NCT06632522
Study groupRoleWhat they receive
radiotherapy combined with Camrelizumab and ApatinibExperimentalradiotherapy combined with Camrelizumab and Apatinib in the treatment of liver cancer patients with VP4
Receives: Drug: radiotherapy combined with Camrelizumab and Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: up to 3 years

Secondary outcomes (3)

  1. Progression-free survival

    Time elapsed from treatment to death from any cause

    Measured: up to 3 years

  2. Objective response rate

    The proportion of patients with a confirmed complete response or partial response

    Measured: up to 3 years

  3. Disease control rate

    The proportion of patients who have achieved complete remission (CR), partial remission (PR) or disease stability (SD) at least once after receiving the treatment of this research scheme.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start20 Oct 2024 (estimated)
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632522
Sponsor's protocol ID
24250-4-02
Status last verified
Oct 2024
First submitted
5 Sep 2024
Last updated
9 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiotherapy combined with Camrelizumab and Apatinib in people with Liver Cancer, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gong Li, M.A. (13366061906, lga02375@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06632522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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