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Hepatocellular CarcinomaPhase 2CAPTNCT04930315

SHR-1210 Combined With Apatinib Mesylate in the Perioperative Therapy for Hepatocellular Carcinoma

A Phase 2 study testing Apatinib Mesylate and Camrelizumab in people with Hepatocellular Carcinoma, run by Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to compare the efficacy and safety of camrelizumab + apatinib mesylate neoadjuvant therapy combined with camrelizumab adjuvant therapy and camrelizumab adjuvant therapy alone in patients with technically resectable 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?
Apatinib Mesylate and Camrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
15 Sep 2021to 30 Apr 2026
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

  • 1)Aged 18-70 years old, both genders.
  • 2)Histologically confirmed diagnosis of HCC or strictly consistent with the clinical diagnostic criteria for HCC according to AASLD guideline
  • 3)BCLC stage was B / C, or CNLC stage was IIa-IIIb, but technically resectable (the number of tumors was less than 7, accompanied by ipsilateral portal vein or hepatic vein tumor thrombus formation, but no main portal vein, contralateral portal vein, contralateral hepatic vein or inferior vena cava tumor thrombus, no extrahepatic metastasis, estimated residual liver volume > 30% [if patients with liver fibrosis, residual liver volume > 40%])
  • 4)At least one measurable lesion that meet the mRECIST standard, and the lesion has not received radiotherapy, or local treatments
  • 5)Child-Pugh score: A grade
  • 6)ECOG PS 0-1 points.
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  • 7)The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) :
  • Neutrophils ≥1.5×109/L
  • Platelet count ≥100×109/L
  • Hemoglobin ≥90g/L
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN)
  • AST or ALT levels ≤ 1.5 times the upper limit of normal value (ULN);
  • Serum albumin ≥ 30 g / L
  • Thyroid stimulating hormone (TSH) ≤ ULN
  • Subjects who did not receive anticoagulant therapy: International standardized ratio INR or Partial thromboplastin time APTT≤1.5×ULN; subjects received prophylactic anticoagulant therapy, INR≤1.5×ULN and APTT ≤ ULN within 14 days before the start of study treatment;
  • Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) and creatinine clearance ≥60 ml/min (Cockcroft-Gault formula)
  • 8)If HBsAg (+) and / or anti HCV (+), according to the results of HBV DNA or HCV RNA detection, antiviral therapy should be carried out according to the standard
  • 9)Women of childbearing age should with negative serum or urine pregnancy tests within 14 days prior to study inclusion and who must be non-lactating, and patient should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within 60 days of the end of medication
  • 10)Males with partner of childbearing age should agree to use contraceptives during the study period and for 120 days after the end of the study period;
  • 11)Subjects have good compliance and cooperate with the follow-up.

Who cannot join

  • 1)Known hepatobiliary cell carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma;
  • 2)Co-infection with hepatitis B and C, or co-infection with hepatitis B and D
  • 3)Active malignancies other than HCC within 5 years or concurrently, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and papillary thyroid cancer
  • 4)Subjects has received radical hepatectomy, systemic anticancer therapy for HCC (mainly including systemic chemotherapy, molecular targeted therapy and CTLA-4, PD-1 / PD-L1 monoclonal antibody immunotherapy) and local treatment for liver, including TACE, TAE, tare or local ablation, radiotherapy, etc
  • 5)Presence of the following within 3 months prior to study entry: myocardial infarction, severe unstable angina, NYHA class 2 or higher cardiac insufficiency, poorly controlled arrhythmias, symptomatic congestive heart failure, cerebrovascular accident.
  • 6)Having hypertension that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous history of hypertension crisis or hypertensive encephalopathy;
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  • 7)Active pulmonary tuberculosis or pulmonary tuberculosis history
  • 8)Subject has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma have been completely relieved and may be included as adults without any intervention;Asthma requiring medical intervention with bronchodilators will not be included);
  • 9)Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy
  • 10)Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment;
  • 11)Abnormal coagulation (INR > 1.5 or APTT > 1.5 x ULN) with bleeding tendency or on thrombolytic or anticoagulant therapy
  • 12)The presence of clinically significant bleeding symptoms or a definite bleeding tendency within 3 months prior to study entry, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood +++ or more at baseline, or vasculitis. Gastroscopy was performed if fecal occult blood was positive at baseline, or if it was an observable bloody stool. If gastroscopy indicated severe esophageal varices, it could not be included
  • 13)Known hypersensitivity to apatinib, camrelizumab or drug excipients; or severe allergic reactions to other monoclonal antibodies
  • 14)Subject has active infection or unexplained fever of >38.5 degrees during screening and before first administration (subject's fever due to tumor can be enrolled according to the investigator's judgment);
  • 15)Grade III or above myelosuppression (WBC < 1.9) × 109 / L, hemoglobin lower than 79 g / L, platelet lower than 49 g / L × 109/L）
  • 16)Severe liver dysfunction, serum albumin less than 28 g/L, or serum bilirubin more than 50 μmol/L, or serum alanine transferase was 1.5 times higher than normal
  • 17)HIV positive (HIV 1/2 anti-body)
  • 18)Live vaccine is administered less than 30 days before or possibly during the study period;
  • 19)The subject has a known history of psychotropic substance abuse, alcohol abuse or drug abuse;
  • 20)Researchers think that should be left out in this study, the researchers determine, for example, the subjects have other factors that may result in this study were forced to midway termination, such as, other serious disease (including mental illness) need to merge treatment, there are serious abnormal laboratory examination, accompanied by factors such as family or society, will affect the safety of the subjects, or information and the collection of the sample.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: SHR-1210 Combined With Apatinib Mesylate in the Perioperative Therapy for Technically Resectable Hepatocellular Carcinoma

The purpose of this study was to compare the efficacy and safety of camrelizumab + apatinib mesylate neoadjuvant therapy combined with camrelizumab adjuvant therapy and camrelizumab adjuvant therapy alone in patients with technically resectable hepatocellular carcinoma.

Read the detailed description

The purpose of this study was to compare the efficacy and safety of camrelizumab + apatinib mesylate neoadjuvant therapy combined with camrelizumab adjuvant therapy and camrelizumab adjuvant therapy alone in patients with technically resectable hepatocellular carcinoma. There are two groups:

  1. Neoadjuvant and adjuvant group: (1) Preoperative：Camrelizumab ：200mg, iv, d1, q2w, 4 cycles；apatinib：250mg, po, qd, q2w, 3 cycles; (2) Operation; (3) Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 8 cycles.
  2. Adjuvant group: (1) Operation; (2) Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 12 cycles.
Being tested
Apatinib Mesylate, Camrelizumab
Keywords
Hepatocellular Carcinoma, neoadjuvant therapy, adjuvant therapy
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 MesylateDrug

    250mg, po, qd, q2w in neoadjuvant and adjuvant group, before surgery

  • CamrelizumabDrug

    200mg, iv, d1, q2w, both in two groups

Study groups in NCT04930315
Study groupRoleWhat they receive
neoadjuvant and adjuvant groupExperimentalPreoperative：Camrelizumab ：200mg, iv, d1, q2w, 4 cycles；apatinib：250mg, po, qd, q2w, 3 cycles Operation Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 8 cycles
Receives: Drug: Apatinib Mesylate; Drug: Camrelizumab
adjuvant groupActive comparatorOperation Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 12 cycles
Receives: Drug: Camrelizumab

What is being measured

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

  1. 1-year event-free survival rate

    The proportion of patients who had tumor progression, tumor recurrence (local, regional or distant) or death within 1 year after surgery, whichever occurred first

    Measured: Up to one years

Secondary outcomes (9)

  1. Overall survival (OS)

    Overall survival (OS) refers to the time from enrollment to death due to any cause.

    Measured: Up to 2 years.

  2. Recurrence free survival (RFS)

    From radical resection to the date of the first documented tumor into recurrence or death from any cause, whichever occurred first

    Measured: Up to 2 years

  3. 1-year survival rate

    The proportion of patients without death within 1 year after randomization

    Measured: Up to 1 years

  4. R0 resection rate

    The proportion of patients with negative resection margin among patients undergoing surgery

    Measured: Up to 2 years.

  5. Major pathological response (MPR)

    Number of participants experiencing the percentage of the non-viable cancer cells (necrotized or fibrotized) out of the surface expression of the total tumor area is <10%

    Measured: Up to 2 years.

  6. Pathological Complete Response (pCR)

    After neoadjuvant therapy, no evidence of malignant histology was found in the pathological examination of primary tumor or only carcinoma in situ was found

    Measured: Up to 2 years.

  7. Surgical resection rate

    the proportion of patients who can accept surgical resection after neoadjuvant therapy

    Measured: Up to 2 years.

  8. Adverse events

    Time Frame: 48 months

    Measured: Safety evaluation was done continuously during treatment by using CTCAE 5.0

  9. Event-free survival

    From study treatment to the date of the first documented tumor into progression, recurrence or death from any cause, whichever occurred first

    Measured: Upto 2 years

Timeline

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

  1. First posted18 Jun 2021
  2. Study start15 Sep 2021
  3. Primary completion16 May 2024
  4. Study completion30 Apr 2026

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930315
Sponsor's protocol ID
CISLD-11
Acronym
CAPT
Status last verified
Jun 2023
First submitted
9 Jun 2021
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib Mesylate and Camrelizumab in people with Hepatocellular Carcinoma, run by Zhejiang 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 20 inclusion and 20 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: finished, as of the sponsor's last update on 21 Jul 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year event-free survival rate (time frame: Up to one 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 NCT04930315.

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 21 Jul 2026.

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