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Hepatocellular CarcinomaPhase 2NCT04411706

A Study of Sintilimab Combined With Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma

A Phase 2 study testing Sintilimab Combined With Apatinib and Capecitabine in people with Hepatocellular Carcinoma, run by Xin-Hua Xu 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study aims to evaluate the efficacy and safety of Sintilimab (an Anti-PD-1 Inhibitor) combined with apatinib and capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sintilimab Combined With Apatinib and Capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
21 Jun 2020to 1 Jun 2022
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has given written informed consent.
  • Age between 18-75 years old.male or female.
  • Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1 standard.
  • Subjects haven't received any systemic treatment that includes target-therapy, immunotherapy or chemotherapy for HCC before admission.
  • liver function status Child-Pugh Class A; Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C；
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1；
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  • Expected survival ≥12 weeks
  • 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
  • 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)
  • Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）
  • Serum creatinine ≤1.5×ULN or creatinine clearance > 50 mL/minute (using Cockcroft-Gault formula)

Who cannot join

  • Patients must not have had prior treatment with Sintilimab or any other PD-L1 or PD-1 antagonists.
  • Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed.
  • Known history of hypersensitivity to any components of the Sintilimab formulation, or other antibody formulation.
  • Active central nervous system (CNS) metastases with clinical symptoms (including cerebral edema, steroid requirement, or progressive disease).
  • Patients with other malignant tumor (except cured skin basal cell carcinoma and cervical carcinoma).
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  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) < 50%.
  • Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
  • Coagulation abnormalities (PT>16s、APTT>43s、TT>21s、Fbg<2g/L), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy. Patients with or previous with serious hemorrhage (bleeding > 30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack).
  • Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc.
  • Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.
  • History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis (transaminase does not meet the inclusion, hepatitis B virus (HBV) DNA ≥10⁴ /ml or hepatitis C virus (HCV) RNA≥103 /ml or higher)
  • Participated in other clinical trials, or finish other clinical trials within 4 weeks. Patients who may receive other anti-tumor systemic chemotherapy during the study.
  • Patients who may receive vaccination during the study, or previous had vaccination within 4 weeks.
  • Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.

Trial locations and contacts

1 site in 1 country.

Xinhua Xu, Master contact

+8613986747496 ext. +8613986747496

2732774352@qq.com

Lu Xu, Phd contact

+8613972032135

xlnick@qq.com

China1 site, 1 recruiting

  • Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

    Yichang, Hubei, 443003

    Xinhua Xu, +8613986747496 ext. +8613986747496, 2732774352@qq.com

    Recruiting

Other trials in China

About this study

Official title: a Phase II, Open-label, Single Arm Study of Sintilimab (an Anti-PD-1 Inhibitor) Combined With Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma

This study aims to evaluate the efficacy and safety of Sintilimab (an Anti-PD-1 Inhibitor) combined with apatinib and capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma.

Being tested
Sintilimab Combined With Apatinib and Capecitabine
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Sintilimab Combined With Apatinib and CapecitabineDrug

    Drug: Sintilimab 200mg (3mg/kg for underweight patients) intravenously, every 21 days for a cycle;

    Drug: Apatinib,250mg po qd, for continuous medication;

    Drug: Capecitabine,1000mg/m2 po bid, d1-d14, every 21 days for a cycle;

Study groups in NCT04411706
Study groupRoleWhat they receive
Sintilimab+Apatinib+CapecitabineExperimental=Drug: Sintilimab（i.v）+apatinib（p.o）+capecitabine（p.o）
Receives: Drug: Sintilimab Combined With Apatinib and Capecitabine

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: 1 year after the last patient's enrollment

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: 1 year after the last patient's enrollment

  2. Duration of Response (DoR)

    Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: 1 year after the last patient's enrollment

  3. Overall survival(OS)

    the date of Death of any causes since the date of enrollment

    Measured: 1 year after the last patient's enrollment

  4. Progression-free survival(PFS)

    Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: 1 year after the last patient's enrollment

  5. Safety as measured by the rate of AEs

    The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: 1 year after the last patient's enrollment

Timeline

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

  1. First posted2 Jun 2020
  2. Study start21 Jun 2020
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2022 (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
NCT04411706
Sponsor's protocol ID
CTGU005
Status last verified
Jun 2020
First submitted
28 May 2020
Last updated
24 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li D, Xu L, Ji J, Bao D, Hu J, Qian Y, Zhou Y, Chen Z, Li D, Li X, Zhang X, Wang H, Yi C, Shi M, Pang Y, Liu S, Xu X. Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study. Front Immunol. 2022 Aug 26;13:944062. doi: 10.3389/fimmu.2022.944062. eCollection 2022.

    PubMed 36091003

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab Combined With Apatinib and Capecitabine in people with Hepatocellular Carcinoma, run by Xin-Hua Xu 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 13 inclusion and 15 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 24 Jun 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 Xinhua Xu, Master (+8613986747496 ext. +8613986747496, 2732774352@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 1 year after the last patient's enrollment). 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 NCT04411706, 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 24 Jun 2020.

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