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Hepatocellular Carcinoma Non-resectablePhase 2REGSINNCT04718909

Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC

A Phase 2 study testing Regorafenib + sintilimab and Regorafenib in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is conducted to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for patients with unresectable hepatocellullar carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma Non-resectable
What is being tested?
Regorafenib + sintilimab and Regorafenib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
1 siteChina
Study dates
9 Jan 2021to 31 Dec 2023
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

  • Patients with unresectable HCC confirmed by histology/cytology or clinically.
  • Failure to prior sorafenib or lenvatinib treatment, or intolerance to sorafenib or lenvatinib.
  • For patients who cannot tolerant to sorafenib or lenvatinib, the AEs must resolve to ≤ grade 1 (NCI-CTCAE v5.0) before randomization.
  • Child-Pugh class A.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
  • At least one measurable lesion.
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  • Adequate organ and hematologic function.
  • Life expectancy of at least 3 months.
  • For women of childbearing potential and for men: agreement to remain abstinent.

Who cannot join

  • Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Diffuse HCC.
  • Portal vein tumor thrombus (PVTT) involves the main trunk and contralateral branch or upper mesenteric vein.
  • Inferior vena cava tumor thrombus.
  • Metastatic disease that involves major airways or blood vessels.
  • Symptomatic, untreated or progressing central nervous system metastasis.
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  • History of hepatic encephalopathy
  • History of organ and stem cell transplantation
  • Uncontrolled ascites, hydrothorax or pericardial effusion
  • Patients who receive systemic therapy except for sorafenib and lenvatinib within 4 weeks before randomization, including other molecular targeted drugs, chemotherapy (including hepatic arterial infusion chemotherapy), immunotherapy, and herbal therapy or traditional Chinese medicine with anti-cancer activity.
  • Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment.
  • Untreated or incompletely treated esophageal and/or gastric varices with high-risk for bleeding.
  • History of venous thromboembolism, but implantable i.v. ports, catheter-derived thrombosis, superficial venous thrombosis, or thrombosis effectively treated by regular anticoagulant therapy are excluded.
  • Use of anticoagulants which need monitoring of international normalized ratio.
  • Patients unable to swallow oral medications; Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that may affect the absorption of regorafenib.
  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture underwent major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks; non-recovery from side effects of these procedure.
  • Active tuberculosis.
  • History of malignancy other than HCC within 5 years prior to screening. Patients with skin basal cell carcinoma, skin squamous cell carcinoma, or carcinoma in situ (e.g., breast carcinoma and cervical carcinoma in situ) who have received potentially curative treatment is allowed.
  • Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required.
  • Co-infection of hepatitis B virus (HBV) and hepatitis C virus (HCV) or HBV and hepatitis D virus (HDV).
  • Active infection requiring systemic treatment. Hepatitis B without active replication is allowed. Hepatitis C not requiring antiviral treatment is allowed.
  • Use of antibiotics within 2 weeks prior to injection of sintilimab.
  • Use of immunosuppressive drugs in the past 4 weeks, excluding the routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10 mg/day of prednisone or equivalent). Temporary use of glucocorticoids for dyspnea symptoms such as asthma and chronic obstructive pulmonary disease is allowed.
  • History of idiopathic pulmonary fibrosis, interstitial pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis.
  • Autoimmune disease or immune deficiency.
  • Inadequately controlled hypertension; history of hypertensive crisis or hypertensive encephalopathy.
  • Female patients who are pregnancy or breastfeeding.
  • Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

Other trials in China

About this study

Official title: Regorafenib Combined With Sintilimab Versus Regorafenib Alone as the Second-line Treatment for Unresectable Hepatocellular Carcinoma

This study is conducted to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for patients with unresectable hepatocellullar carcinoma (HCC).

Read the detailed description

This is an open-label, multicenter, randomized controlled trial to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for unresectable HCC.

180 patients with unresectable HCC who progress after sorafenib or lenvatinib treatment or are intolerant to these drugs will be enrolled in the study. The Patients will be treated with regorafenib plus sintilimab or regorafenib alone using an 1:1 randomization scheme.

Regorafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. The administration of regorafenib will be delayed in cases of severe toxicities. And after recovery, regorafenib will be reintroduced at a reduced dose according to the dose delay and reduction guidelines. Treatment of sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. In the arm of regorafenib plus sintilimab, patients will be allowed to have regorafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Being tested
Regorafenib + sintilimab, Regorafenib
Keywords
Hepatocellular carcinoma, Regorafenib, Sintilimab, Second-line treatment
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Regorafenib + sintilimabDrug

    Regorafenib: 160 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off).

    Sintilimab: 200mg i.v. q3w.

  • RegorafenibDrug

    160 mg p.o. qd for 3 weeks of every 4 week cycle.

Study groups in NCT04718909
Study groupRoleWhat they receive
Regorafenib + sintilimabExperimentalRegorafenib combined with sintilimab.
Receives: Drug: Regorafenib + sintilimab
RegorafenibActive comparatorRegorafenib alone.
Receives: Drug: Regorafenib

What is being measured

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

  1. Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST)

    The time from date of randomization until the first occurrence of disease progression or death due to any cause, whichever occurs first.

    Measured: 24 months

Secondary outcomes (9)

  1. Adverse Events (AEs)

    Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

    Measured: 24 months

  2. Overall survival (OS)

    The time from date of randomization to death due to any cause.

    Measured: 24 months

  3. Time to Progression (TTP) assessed by investigators according to RECIST 1.1 and irRECIST

    The time from date of randomization until the first occurrence of disease progression.

    Measured: 24 months

  4. Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST.

    The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

    Measured: 24 months

  5. Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST

    The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).

    Measured: 24 months

  6. PFS assessed by investigators according to Modified RECIST (mRECIST)

    The time from date of randomization until the first occurrence of disease progression or death due to any cause, whichever occurs first.

    Measured: 24 months

  7. TTP assessed by investigators according to mRECIST.

    The time from date of randomization until the first occurrence of disease progression.

    Measured: 24 months

  8. ORR assessed by investigators according to mRECIST

    The percentage of patients who had a best overall tumor response rating of CR or PR.

    Measured: 24 months

  9. DCR assessed by investigators according to mRECIST.

    The percentage of patients who had a tumor response rating of CR, PR, or SD.

    Measured: 24 months

Timeline

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

  1. First posted22 Jan 2021
  2. Study start9 Jan 2021
  3. Primary completion8 Jul 2023 (estimated)
  4. Study completion31 Dec 2023 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718909
Sponsor's protocol ID
MIIR-05
Acronym
REGSIN
Status last verified
Nov 2022
First submitted
20 Jan 2021
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib + sintilimab and Regorafenib in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou 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 9 inclusion and 28 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 10 Nov 2022. 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?

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?

Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST) (time frame: 24 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 NCT04718909.

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 10 Nov 2022.

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