PD-1 Monoclonal Antibody Plus Apatinib Combined With SBRT in HCC With PVTT

NCT04165174 | Unknown Phase 2

• 1 other identifier: TJCC 010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

It is a trial to assess the efficacy and safety of PD-1 monoclonal antibody plus Apatinib combined with SBRT as first-line treatment in HCC with PVTT.

Conditions

HCC

Keywords

HCC; PVTT; PD-1; Apatinib; SBRT

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS is defined as time from the start of treatment to progression of disease or death.

  up to 3 years

Secondary Outcomes (5)

• OS

  up to 3 years

• ORR

  up to 3 years

• DCR

  up to 3 years

• TTSP

  up to 3 years

• Safety as measured by number and grade of adverse events

  up to 3 years

Study Arms (1)

PAS

EXPERIMENTAL

PD-1:240mg,ivdrip,Q3W,begin with SBRT Apatinib:250mg,po,QD,begin with SBRT SBRT:6-10Gy/F,5-8F

Drug: Terepril monoclonal antibody; Apatinib; Radiation: SBRT

Interventions

Terepril monoclonal antibody; Apatinib DRUG

Terepril monoclonal antibody,240mg,ivdrip,Q3W Apatinib,250mg,po,QD

PAS

SBRT RADIATION

6-10Gy/F,5-8F

PAS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with primary hepatocellular carcinoma confirmed by cell or histopathology were complicated with PVTT and BCLC stage C.
• \. According to RECIST criteria, there is at least one measurable lesion, which is a lesion other than SBRT.
• \. Child-Pugh A or partial B grade of liver function (recovered to A grade after supportive treatment); normal liver volume \> 700 ml;
• \. Renal function: Serum creatinine \< 1.5 times normal upper limit;
• \. ECOG score 0-1;
• \. The life expectancy is more than 3 months.
• \. There were no obvious signs of hematological diseases, ANC (\> 1.5 \*109/L), platelet count (\> 75 \*109/L) and no tendency of bleeding before enrollment, HGB (\> 90 g/L) and INR (\< 2.5 times normal upper limit and APT (\< 1.5 times normal upper limit).
• \. FT3, FT4 and TSH are within the normal range of 10%.
• \. No history of abdominal irradiation.
• \. Patients with other previous malignant tumors had a disease-free survival of more than 2 years after initial treatment (e.g. non-melanoma skin cancer or cervical cancer in situ).
• \. The patient signed the informed consent.
• \. Female patients of childbearing age or male patients whose sexual partners are women of childbearing age need to take effective contraceptive measures during the whole treatment period and within 6 months after treatment.
• It is better to provide tissue samples for biomarker analysis (e.g. PD-L1) and to optimize newly acquired tissues. Patients who are unable to provide newly acquired tissues can provide 5-8 paraffin sections of 3-5 micron thickness for archival preservation.

You may not qualify if:

• \. History of hepatic encephalopathy or liver transplantation;
• \. Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion, asymptomatic;
• \. Untreated hepatitis infection: HBV DNA \> 2000iu/ml, HCV RNA \> 103copy/ml, HBsAg and anti-HCV antibodies were positive.
• \. Distant metastasis.
• \. In the past six months, there have been history of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive intestinal resection (partial or extensive enterectomy for chronic diarrhea), Crohn's disease, ulcer, etc. Acute colitis or chronic diarrhea;
• \. Symptomatic history of interstitial lung disease or other conditions that may lead to confusion in the detection or management of suspected drug-related pulmonary toxicity;
• \. Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active pulmonary tuberculosis infection within one year should be excluded even if they have received treatment.
• \. Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) positive;
• \. Severe infections are active or under clinical control. Severe infections occurred within 4 weeks before the first treatment, including but not limited to hospitalization due to infections, bacteremia or complications of severe pneumonia.
• \. Patients with active, known or suspected autoimmune diseases. Patients with vitiligo, type I diabetes mellitus, thyroid dysfunction caused by autoimmune thyroiditis (only hormone replacement therapy) or diseases that do not recur without external stimuli can be selected.
• \. Immunosuppressive drugs used in the past four weeks, excluding local or systemic glucocorticoids (i.e., prednisone or other equivalent doses of glucocorticoids not exceeding 10 mg/day), through nasal sprays, inhalation or other routes, and temporarily using glucocorticoids to treat dyspnea symptoms of asthma, Chronic obstructive pulmonary disease;
• \. Any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.) have been vaccinated in the past four weeks.
• \. Receiving systemic immune stimulation therapy in the past four weeks;
• \. In the past four weeks, major operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures have been performed.
• Uncontrolled metabolic disorders or other non-malignant organs or systemic diseases or secondary tumors may lead to higher medical risks and/or uncertainty in survival assessment;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Interventions

apatinib

Study Officials

• Xianglin Yuan, MD,PhD

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Xianglin Yuan, MD,PhD

CONTACT

8627-83663406; xlyuan1020@163.com

Yanmei Zou, MD,PhD

CONTACT

8627-83663406; zouyanmei0101@126.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: Professor, Head of the cancer center

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: November 15, 2019
• Study Start: December 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 15, 2019

Record last verified: 2019-11

Locations

CN (1)