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Hepatocellular CarcinomaPhase 2HCC-009NCT04297202

SHR-1210 Combined With Apatinib Mesylate in the Perioperative Treatment of Hepatocellular Carcinoma

A Phase 2 study testing Apatinib Combined With SHR-1210 Injection in people with Hepatocellular Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of HCC. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Apatinib Combined With SHR-1210 Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Dec 2019to 1 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The patient volunteered to participate in the study and signed an informed consent form
  • ≥18 years of age，Male or female
  • Subjects are diagnosed with histologically or cytologically confirmed HCC
  • Subjects haven't received any systemic treatment for HCC before admission.
  • Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard
  • ECOG performance status of 0 or 1
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  • Life expectancy ≥ 12 weeks
  • Subjects are diagnosed with resectable stage IIB, stage IIIA HCC cancer.
  • The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)
  • Absolute neutrophil count≥1.5×109 /L
  • Platelets≥80×109/L ;Hemoglobin≥9.0 g/dL; Serum albumin≥3g/dL
  • Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）
  • Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)
  • Serum creatinine ≤1.5×ULN or creatinine clearance > 60 mL/minute (using Cockcroft-Gault formula)

Who cannot join

  • Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
  • Be ready for or previously received organ or allogenic bone marrow transplantation
  • Moderate-to-severe ascites with clinical symptoms
  • History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.
  • Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment.
  • Known genetic or acquired hemorrhage or thrombotic tendency.
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  • The patient is currently using or has recently used (within 10 days before the start of study treatment) aspirin (> 325mg / day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol.
  • Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
  • Cardiac clinical symptom or disease that is not well controlled.
  • Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment ；Subjects have had a hypertensive crisis or hypertensive encephalopathy
  • Patient develops severe vascular disease within 6 months before the start of study treatment.
  • Patients with severe, unhealed or split wounds and active ulcers or untreated fractures
  • Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment.
  • Factors to affect oral administration (such as patients unable to swallow oral medications, malabsorption syndrome etc. situations evidently affect drug absorption).
  • Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.
  • There is evidence of intragastric gas that cannot be explained by puncture or recent surgery.
  • Previous or current presence of metastasis to central nervous system.
  • Subjects have history of hepatic encephalopathy.
  • The subject has an interstitial lung disease that is symptomatic or may interfere with the discovery or management of suspected drug-related lung toxicity; previous and current subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-associated pneumonia, severe impaired lung function, etc.
  • The patient has any active autoimmune disease or a history of autoimmune disease expected relapse.
  • Severe infection within 4 weeks prior to the start of study treatment.
  • A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease.
  • Prior therapy with any anti-PD-1/PD-L1 drug (specifically targeting T-cell co-stimulation or checkpoint pathways), Sorafenib or Apatinib.
  • Subjects were vaccinated with live attenuated vaccine within 28 days before the first dose or expected to receive this vaccine within 60 days after the last dose or during the study period.
  • Treatment of other investigational product(s) within 28 days prior to the start of study treatment.

Trial locations and contacts

1 site in 1 country.

Xuehao Wang contact

86-025-68303211

Wangxh@njmu.edu.cn

China1 site, 1 recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Xuehao Wang, 86-025-68303211, wangxh@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Open-label, Single Arm, Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in the Perioperative Treatment of Hepatocellular Carcinoma

This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of HCC.

Read the detailed description

This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Apatinib Combined With SHR-1210 (an Anti-PD-1 Inhibitor) in Patients With Hepatocellular Carcinoma(HCC) as Perioperative Treatment. we conduct this study in order to observe and evaluate the efficacy and safety of Apatinib combined with SHR-1210 (an Anti-PD-1 Inhibitor) in treatment of patients with HCC. Primary Efficacy Endpoint: Major pathologic response (MPR), Secondary Efficacy Endpoints: Pathological complete response Rate (pCR), Objective Response(ORR) (According to RECIST Version 1.1), Recurrence-free survival(RFS) and Overall survival rate of 6 months (OS %-6 m). Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.3.

Being tested
Apatinib Combined With SHR-1210 Injection
Keywords
Hepatocellular Carcinoma, the Perioperative Treatment, HCC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Apatinib Combined With SHR-1210 InjectionDrug

    3 cycles of neoadjuvant therapy before surgery, two weeks is a treatment cycle: D1、D15、D31 : SHR-1210 200mg, I.V, q2w； D1-D20 : Apatinib 250 mg, orally, qd; D46 : Patients were preoperatively evaluated. Operable patients were scheduled for hepatectomy with/without microwave ablation; After 4 to 8 weeks after liver resection, a postoperative adjuvant program is performed. Three weeks is a treatment cycle with a total of 8 cycles

    In each cycle:

    D1: SHR-1210 200mg, I.V, q3w; D1-D21: Apatinib 250mg, orally, qd;

Study groups in NCT04297202
Study groupRoleWhat they receive
Apatinib Combined With SHR-1210 InjectionExperimentalSHR-1210 Injection: 3 cycles of neoadjuvant therapy before surgery, two weeks is a treatment cycle; Apatinib : D1-D21 : 250 mg, orally, qd; Before surgery, the patient's surgical pathology samples still need to be collected. D46 : Patients were preoperatively evaluated. Operable patients were scheduled for hepatectomy with/without microwave ablation; After 4 to 8 weeks after liver resection, a postoperative adjuvant program is performed. The cycle of a three-week plan will be performed with a total of 8 cycles with the treatment of Apatinib combination with SHR-1210 Injection.
Receives: Drug: Apatinib Combined With SHR-1210 Injection

What is being measured

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

  1. Major pathologic response

    It is defined as residual tumors less than 10% after neo-adjuvant therapy

    Measured: 6 months

Secondary outcomes (6)

  1. Pathological complete response

    No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors

    Measured: 6 months

  2. Objective Response(ORR)

    It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.

    Measured: Before surgery；

  3. Recurrence free survival(RFS)

    from surgery to relapse or death resulting from any cause .

    Measured: through study completion, an average of 1 year

  4. Recurrence free survival rates of 6 months and 12 months

    the rate of proportion of all patients from surgery to relapse or death resulting from any cause.

    Measured: 12 months

  5. Overall survival rate (6 m or 12 m)

    It is defined as the time from randomization to death from any cause during the course of the study

    Measured: through study completion; the rate of OS for 6 months and 12 months

  6. Safety as measured by the rate of AEs

    Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.3

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted5 Mar 2020
  2. Study start1 Dec 2019
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Dec 2021 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297202
Sponsor's protocol ID
2019-SR-332
Acronym
HCC-009
Status last verified
Aug 2020
First submitted
30 Jan 2020
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xia Y, Tang W, Qian X, Li X, Cheng F, Wang K, Zhang F, Zhang C, Li D, Song J, Zhang H, Zhao J, Yao A, Wu X, Wu C, Ji G, Liu X, Zhu F, Qin L, Xiao X, Deng Z, Kong X, Li S, Yu Y, Xi W, Deng W, Qi C, Liu H, Pu L, Wang P, Wang X. Efficacy and safety of camrelizumab plus apatinib during the perioperative period in resectable hepatocellular carcinoma: a single-arm, open label, phase II clinical trial. J Immunother Cancer. 2022 Apr;10(4):e004656. doi: 10.1136/jitc-2022-004656.

    PubMed 35379737

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib Combined With SHR-1210 Injection in people with Hepatocellular Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University 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 14 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 7 Aug 2020. 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?

Results are not available in the source record.

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

Contact Xuehao Wang (86-025-68303211, Wangxh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathologic response (time frame: 6 months). 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 NCT04297202, which also lists 1 linked publication.

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 7 Aug 2020.

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