Advanced Hepatocellular CarcinomaPhase 1NCT04072679
Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma
A Phase 1 study testing Sintilimab+IBI305 in people with Advanced Hepatocellular Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Sintilimab+IBI305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2018to 11 Nov 2020
- Phase
- Phase 1
- 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
- Local advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
- Barcelona Clinic Liver Cancer (BCLC) C. BCLC B, unsuitable for local treatments or local treatments failure.
- Patients who failed to or unsuitable for the previously systemic chemotherapy, sorafenib, lenvatinib, regorafenib or similar drug failure (disease progression or toxicity intolerance).
- At least one measurable lesion per RECIST V1.1 that has not been treated locally or that has progressed after local treatment.
- Child-Pugh score ≤ 7 points.
- ECOG：0 or 1.
- Adequate organ and bone marrow function.
Who cannot join
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
- HBV DNA>2000 IU/ml or 104 copies/ml for acute or chronic active hepatitis B or hepatitis C; HCV RNA>103 copies/ml; both HbsAg and anti-HCV antibody are positive.
- Esophageal or gastric varices bleeding caused by portal hypertension occurred in the past 6 months. Patients with endoscopy evidence of severe varices (G3) within 3 months. Patients with portal hypertension in high risk of bleeding evaluated by investigator.
- History of venous thromboembolism in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolism. Implantable IV ports or catheter-derived thrombosis, superficial venous thrombosis, or thrombosis after conventional anticoagulant therapy are excluded. Prophylactic uses of low-dose aspirin or low molecular weight heparin is allowed.
- Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
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- Uncontrolled high blood pressure, systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after optimal medical treatment; Hypertensive crisis or history of hypertensive encephalopathy.
- History of gastrointestinal perforation and/or fistula in the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) , complicated by chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea.
- History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia. Allow radioactive pneumonia in the radiotherapy area.
- Active tuberculosis (TB), who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before inclusion.
- HIV infected (HIV 1/2 antibody positive).
- 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.
- Have undergone major surgery (craniotomy, thoracotomy or open surgery) or unhealed wounds, ulcers or fractures within 4 weeks.
- Previously received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA4 antibodies, or other immunotherapy; previously received anti-VEGF monoclonal antibody treatment.
- Female patients who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, 100021
About this study
Official title: Evaluation of the Safety and Efficacy of Sintilimab Combined With IBI305 in the Treatment of Advanced Hepatocellular Carcinoma in a Single-center, One-arm, and Phase Ib Study
This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.
Read the detailed description
This study is to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.
Approximately 26-38 subjects with locally advanced or metastatic hepatocellular carcinoma will be enrolled in the study. It includes dose escalation and dose expansion stage. 12-18 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 20 patients for the further safety and efficacy study.
The study treatment lasts 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.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Sintilimab+IBI305
- Keywords
- Advanced Hepatocellular Carcinoma, Sintilimab, IBI305
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab+IBI305Drug
It includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 36-39 patients for the further safety and efficacy study.The study treatment lasts up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab+IBI305 | Experimental | Sintilimab: 200mg (D1, q3w） IBI305: 7.5mg/kg or 15mg/kg (D1, q3w） Receives: Drug: Sintilimab+IBI305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incicende of Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.
Measured: 2 years
Secondary outcomes (7)
Objective Response Rate (ORR)
Investigator assessed according to RECIST v1.1
Measured: 2 years
Time to response (TTR)
Investigator assessed according to RECIST v1.1
Measured: 2 years
Duration of response (DOR)
Investigator assessed according to RECIST v1.1
Measured: 2 years
Disease control rate (DCR)
Investigator assessed according to RECIST v1.1
Measured: 2 years
Progression free survival (PFS)
Investigator assessed according to RECIST v1.1
Measured: 2 years
Overall Survival (OS)
Investigator assessed according to RECIST v1.1
Measured: 2 years
Anti-drug antibody (ADA)
Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start11 Oct 2018
- Primary completion31 Mar 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Aiping Zhou Zhou, Doctor, Principal investigator, National Cancer Center/Cancer Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072679
- Sponsor's protocol ID
- CIBI338B101
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Sintilimab Combined With IBI305 in the Treatment of Advanced Hepatocellular Carcinoma in a Single-center, One-arm, and Phase Ib Study
- ClinicalTrials.gov ID
- NCT04072679
- Acronym / sponsor ID
- CIBI338B101
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Advanced Hepatocellular Carcinoma, Sintilimab, IBI305
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.
Detailed description
This study is to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.
Approximately 26-38 subjects with locally advanced or metastatic hepatocellular carcinoma will be enrolled in the study. It includes dose escalation and dose expansion stage. 12-18 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 20 patients for the further safety and efficacy study.
The study treatment lasts 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab+IBI305 | Experimental | Drug: Sintilimab+IBI305Sintilimab: 200mg (D1, q3w） IBI305: 7.5mg/kg or 15mg/kg (D1, q3w） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Local advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
- Barcelona Clinic Liver Cancer (BCLC) C. BCLC B, unsuitable for local treatments or local treatments failure.
- Patients who failed to or unsuitable for the previously systemic chemotherapy, sorafenib, lenvatinib, regorafenib or similar drug failure (disease progression or toxicity intolerance).
- At least one measurable lesion per RECIST V1.1 that has not been treated locally or that has progressed after local treatment.
- Child-Pugh score ≤ 7 points.
Key exclusion criteria (15 listed)
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
- HBV DNA>2000 IU/ml or 104 copies/ml for acute or chronic active hepatitis B or hepatitis C; HCV RNA>103 copies/ml; both HbsAg and anti-HCV antibody are positive.
- Esophageal or gastric varices bleeding caused by portal hypertension occurred in the past 6 months. Patients with endoscopy evidence of severe varices (G3) within 3 months. Patients with portal hypertension in high risk of bleeding evaluated by investigator.
- History of venous thromboembolism in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolism. Implantable IV ports or catheter-derived thrombosis, superficial venous thrombosis, or thrombosis after conventional anticoagulant therapy are excluded. Prophylactic uses of low-dose aspirin or low molecular weight heparin is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab+IBI305It includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 36-39 patients for the further safety and efficacy study.The study treatment lasts up to 24 months. | Drug | Sintilimab+IBI305 |
Primary outcome
Incicende of Adverse Events (AEs)
Time frame: 2 years
Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Anti-drug antibody (ADA)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiping Zhou Zhou, Doctor principal investigator
National Cancer Center/Cancer Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sintilimab+IBI305 in people with Advanced Hepatocellular Carcinoma, run by Chinese Academy of Medical Sciences 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 7 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: finished, as of the sponsor's last update on 1 Feb 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incicende of Adverse Events (AEs) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2021.