A Neoadjuvant Hepatocellular Carcinoma Study of Camrelizumab in Combination With Apatinib and Oxaliplatin

NCT04850040 | Unknown Phase 2

• 1 other identifier: NCC2841
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, single-arm, single-center, clinical research.This trial will explore the efficacy and safety of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma Resectable

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response(MPR) 10%

  Survival tumor ≤10% during surgery

  Up to two years

Secondary Outcomes (4)

• ORR

  Up to two years

• 1-year tumor recurrence-free rate RFS

  Up to one years

• Disease free survival (DFS)

  Up to two years

• Intraoperative and postoperative complications

  Up to two years

Study Arms (1)

Camrelizumab+Apatinib Mesylate+Oxaliplatin

EXPERIMENTAL

An study of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma.

Drug: Apatinib Mesylate; Drug: Camrelizumab; Drug: Oxaliplatin

Interventions

Apatinib Mesylate DRUG

250 mg, oral every other day. Approximately half an hour after a meal (the daily dose should be taken at the same time as possible) with warm boiled water.

Camrelizumab+Apatinib Mesylate+Oxaliplatin

Camrelizumab DRUG

200 mg, 30 minutes intravenous drip (overall dosing time no shorter than 20 minutes and no longer than 60 minutes, including tube flush time) once every 2 weeks, with the first dose administered concurrently with Apatinib Mesylate Tablets.

Camrelizumab+Apatinib Mesylate+Oxaliplatin

Oxaliplatin DRUG

85 mg/m2, once every 2 weeks, to be administered half an hour after Camrelizumab injection.

Camrelizumab+Apatinib Mesylate+Oxaliplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years old, both genders.
• ECOG PS 0-1 points.
• Hepatocellular liver cancer with a clinical diagnosis consistent with primary hepatocellular liver cancer and a lesion consistent with the Primary Liver Cancer Diagnostic and Treatment Standards (2019) Edition.
• The hepatobiliary MDT of Cancer Hospital of Chinese Academy of Medical Sciences (MDT) discussed the case as potentially resectable requiring neoadjuvant chemotherapy.
• Locally advanced, potentially resectable tumors. Ruptured liver tumor or adjacent organ invasion without extrahepatic metastasis (imaging confirmed).
• Hepatocellular carcinoma combined with cancerous thrombus in a branch of a grade 1 or 2 vasculature (portal vein, hepatic vein, bile duct) (imaging confirmed).
• Lymph node metastasis (image confirmed). Liver tumor ≥ 5 cm; multiple tumors with ≤ 3 tumors, but located in one lobe (imaging \[CT, MRI or ultrasound\]) Hepatocellular carcinoma tumors located in the middle lobe (segment IV, V, VIII) or caudal lobe of the liver; hepatocellular carcinoma tumors within 1 cm of a branch of a grade 1 or 2 vasculature (portal vein, hepatic vein, bile duct) or involving the above-mentioned vasculature (expected cut edge \< 1 cm).
• Tumor with satellite foci or subfoci. Tumor without envelope or incomplete tumor with envelope, multi-nodal fusion. 6. NRS ≤3 points. 7. Patients who have not received any previous antineoplastic drug treatment. 8. At least 1 measurable lesion that meets RECIST 1.1 criteria. 9. Liver function Child-Pugh score: grade A-B (≤7). 10. Expected survival \> 3 months. 11. Relevant indicators meet the following criteria:
• blood routine examination HB≥90 g/L； ANC≥1.5×109/L； PLT≥75×109/L；
• CMP ALB ≥30g/L； ALT and AST\< 2.5ULN； TBIL ≤1.5 ULN； Cr ≤1.5ULN 12. Women of childbearing age (18-49 years covered by this protocol) must have a negative pregnancy test (serum or urine) result within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug; for men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug.
• \. Patients with HBV or HCV infection are required to be on antiviral therapy for the duration of the trial.
• Subjects voluntarily enrolled in this study, signed informed consent, good compliance and cooperation with follow-up.

You may not qualify if:

• \- Patients will not be entered into this study if they meet any of the following criteria.
• History of other malignancies within the previous 5 years or concurrently, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and papillary thyroid cancer
• History of ruptured esophagogastric fundic varices, hepatic encephalopathy, massive ascites, and abdominal infection
• Patients with previous use of other anti-angiogenic drugs, immunotherapeutic drugs, radiotherapy or systemic chemotherapy
• Prior use of immunosuppressive drugs, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg days of prednisolone or equivalent pharmacologic doses of other corticosteroids), within 14 days prior to the first administration of kareolizumab
• Known hypersensitivity to apatinib, carrilizumab, oxaliplatin, or drug excipients; or severe allergic reactions to other monoclonal antibodies
• Live attenuated vaccines administered within 4 weeks prior to the first dose or scheduled to be administered during the study.
• Known uncontrolled or symptomatic active central nervous system (CNS) metastases as evidenced by the presence of clinical signs, cerebral edema, spinal cord compression, carcinomatous meningitis, soft meningeal disease, and or progressive growth. Patients with a history of CNS metastases or spinal cord compression who are clearly treated and clinically stable after discontinuation of anticonvulsants and steroids for 4 weeks prior to the first dose of the study may be enrolled in the study.
• The presence of \> grade 1 peripheral neuropathy
• The presence of any active autoimmune disease or a history of autoimmune disease
• Presence of the following within 6 months prior to study entry: myocardial infarction, severe unstable angina, NYHA class 2 or higher cardiac insufficiency, poorly controlled arrhythmias (including QTcF intervals \>450 ms in men and \>470 ms in women, QTcF intervals calculated using the Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident ( including transient ischemic attack or symptomatic pulmonary embolism).
• Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
• Abnormal coagulation (INR \> 1.5 or APTT \> 1.5 x ULN) with bleeding tendency or on thrombolytic or anticoagulant therapy
• Known hereditary or acquired bleeding and thrombotic tendencies, e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.
• Presence of significant coughing up of fresh blood, or hemoptysis of half a teaspoon (2.5 ml) or more per day within 2 months prior to study entry

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Interventions

apatinib; camrelizumab; Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Jianping Xu, Master's Degree

CONTACT

13651379626; 13651379626@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: May 6, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share