Combinational ImmunotherapyPhase 1CCGLC-003NCT05031949
Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma
A Phase 1 study testing hyperbaric oxygen therapy plus Camrelizumab in people with Combinational Immunotherapy and Hepatocellular Carcinoma Non-Resectable, run by Zhang Bi Xiang, MD at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of hyperbaric oxygen therapy plus Camrelizumab as a second-line treatment in patients with advanced hepatocellular carcinoma who have failed at least 1 previous treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Combinational Immunotherapy, Hepatocellular Carcinoma Non-Resectable, Hyperbaric Oxygen Therapy
- What is being tested?
- hyperbaric oxygen therapy plus Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2021to 30 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects volunteer to participate in the study and agree to sign the informed consent with good compliance and follow-up.
- Subjects are 18 years old or older when signing the informed consent and gender is not limited.
- Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
- Failed or intolerable to at least one prior systemic treatment for advanced HCC
- With at least one assessment lesion according to the RESIST v1.1 criteria.
- Estimated survival time ≥ 12 weeks.
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- The ECOG score is 0-1 within 1 week before enrollment.
- Adequate organ function, including:
- Whole blood cell examination (no blood transfusion within 14 days, no G-CSF use and no drugs use): Hb≥90g/L, ANC≥1.5×10*9/L, PLT≥70×10*9/L;
- Biochemical examination (no ALB infused within 14 days): ALB≥29 g/L, ALT and AST<5×ULN, TBIL≤1.5×ULN, creatinine≤1.5×ULN, and prothrombin time or INR ≤1.5×ULN;
- thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- Without biliary obstruction. Subjects who need biliary stent implantation must be completed at least 7 days before enrollment
- Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug
- Subjects with asymptomatic or stable brain metastases after local treatment are allowed to be included as long as they meet the following conditions:
- measurable lesions outside the central nervous system;
- No central nervous system symptoms or no aggravation of symptoms for at least 2 weeks;
- Those who do not need glucocorticoid treatment or stop glucocorticoid treatment within 7 days before the administration of the first study drug;
- Patients were allowed to receive palliative radiotherapy, but the end time of radiotherapy was within 7 days before the administration of the first study drug.
Who cannot join
- Subjects with one or more than one of the following criteria should be excluded
- Subjects has contraindications of hyperbaric oxygen use, including pneumothorax, mediastinal edema, multiple rib fractures, open trauma of chest wall, vacuolar pulmonary tuberculosis with hemoptysis, pulmonary bullae, active internal bleeding and hemorrhagic diseases;
- Subjects with other malignant tumors in the past 5 years (radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection of carcinoma in situ were not included);
- subjects are currently participating in other interventional clinical studies, or received any topical treatment within 4 weeks prior to the study, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection;
- systemic treatment with traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration;
- Diagnosis of immunodeficiency or systemic steroid therapy or any form of immunosuppressants therapy within 7 days prior to this study. A physiological dose of corticosteroids (no more than 7.5 mg/d prednisone or equivalent) can be approved after clinical evaluation;
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- Pleural effusion or Ascites with clinical symptoms which requires pleural or abdominal puncture or drainage therapy;
- Subjects have organ transplantation history.
- Subjects are allergic to the active ingredients or excipients of Camrelizumab;
- Subjects with multiple factors affecting oral drugs (such as inability to swallow, post gastrointestinal resection, chronic diarrhea and intestinal obstruction);
- Not fully recovered from toxicity and / or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number at the same time was higher than the upper limit of normal value in the laboratory of the research center).Note: hepatitis B patients who meet the following criteria can also be enrolled:
- Before the first administration, the HBV viral load was less than 1000 copies / ml (200 IU / ml). Subjects should receive anti HBV treatment throughout the study chemotherapy treatment to avoid virus reactivation;
- For subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored.
- Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
- Live vaccine was administered within 30 days before the first administration (cycle 1, day 1);Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasal are not allowed.
- Female subjects who are pregnant, breastfeeding or refuse contraception.
- Subjects have any serious or uncontrollable systemic diseases, such as:
- There are significant abnormalities in rhythm, conduction or morphology of resting ECG and the symptoms are serious and difficult to control, such as complete left bundle branch block, heart block above grade II, ventricular arrhythmia or atrial fibrillation;
- Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) grade ≥ 2;
- Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before enrollment;
- Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
- A history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or the current presence of clinically active interstitial lung disease;
- Active pulmonary tuberculosis;
- There are active or uncontrolled infections requiring systemic treatment;
- There were clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction;
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- Diabetes was poorly controlled (fasting blood glucose (FBG) > 10mmol/L).
- Urine routine examination showed that urinary protein was ≥ + +, and the 24-hour urinary protein was confirmed to be more than 1.0 G;
- Subjects with mental disorders and unable to cooperate with treatment;
- Subjects are unsuitable for participation in this research after comprehensive assessment by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ze-yang Ding, M.D., +8613407156200, dingzyang@sina.com
About this study
Official title: A Single-center, Single-arm, Non-randomized Clinical Study to Evaluate the Efficacy and Safety of Hyperbaric Oxygen Therapy Plus Camrelizumab as a Second-line Treatment in Advanced/Metastatic Hepatocellular Carcinoma
The purpose of this study is to explore the efficacy and safety of hyperbaric oxygen therapy plus Camrelizumab as a second-line treatment in patients with advanced hepatocellular carcinoma who have failed at least 1 previous treatment.
- Conditions
- Combinational Immunotherapy, Hepatocellular Carcinoma Non-Resectable, Hyperbaric Oxygen Therapy
- Being tested
- hyperbaric oxygen therapy plus Camrelizumab
- Keywords
- hyperbaric oxygen therapy, Camrelizumab, hepatocellular carcinoma, 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.
hyperbaric oxygen therapy plus CamrelizumabCombination product
Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy plus Camrelizumab | Experimental | Subjects receive Camrelizumab intravenous at the dose 3mg/kg on Day 1 every 3 weeks, and breath pressurized (0.25 MPa) 100% oxygen (O2) indirectly by a head hood or mask for 60 minutes in multiplace chambers at Day 1 of every week. Receives: Combination Product: hyperbaric oxygen therapy plus Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per RECIST v1.1
ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.
Measured: up to 12 months.
Progression-free survival based on RECIST v1.1
Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.
Measured: Time from first treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (4)
Duration of Response Rate per RECIST v1.1
time from the date of CR or PR until PD
Measured: up to 12 months
Disease control rate per RECIST v1.1
Disease control rate (DCR)=CR + PR + stable disease
Measured: up to 12 months
Overall Survival
Duration from the date of initial treatment with hyperbaric oxygen therapy plus Camrelizumab to the date of death due to any cause.
Measured: up to 12 months
Number of Subjects with one or more adverse events as assessed by CTCAE 5.0
Safety and tolerability of hyperbaric oxygen therapy plus Camrelizumab as assessed by the frequency, duration, and severity of adverse events
Measured: From screening through 30-35 days after end of treatment, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start30 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combinational ImmunotherapyStudies 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
- Model description
- A Phase 1b, Open-Label, Single-Arm Study to explore the efficacy and safety of hyperbaric oxygen therapy plus Camrelizumab as a second-line treatment in patients with advanced hepatocellular carcinoma who have failed at least 1 previous treatment.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Bi Xiang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Bi Xiang, MD, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031949
- Sponsor's protocol ID
- 2021-S087
- Acronym
- CCGLC-003
- Status last verified
- Dec 2023
- First submitted
- 31 Aug 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Non-randomized Clinical Study to Evaluate the Efficacy and Safety of Hyperbaric Oxygen Therapy Plus Camrelizumab as a Second-line Treatment in Advanced/Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05031949
- Acronym / sponsor ID
- CCGLC-003 / 2021-S087
- Conditions
- Combinational Immunotherapy, Hepatocellular Carcinoma Non-Resectable, Hyperbaric Oxygen Therapy
- Keywords
- hyperbaric oxygen therapy, Camrelizumab, hepatocellular carcinoma, second-line treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhang Bi Xiang, MDUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Sep 2021 (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.
The purpose of this study is to explore the efficacy and safety of hyperbaric oxygen therapy plus Camrelizumab as a second-line treatment in patients with advanced hepatocellular carcinoma who have failed at least 1 previous treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Phase 1b, Open-Label, Single-Arm Study to explore the efficacy and safety of hyperbaric oxygen therapy plus Camrelizumab as a second-line treatment in patients with advanced hepatocellular carcinoma who have failed at least 1 previous treatment.
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy plus Camrelizumab | Experimental | Combination Product: hyperbaric oxygen therapy plus CamrelizumabSubjects receive Camrelizumab intravenous at the dose 3mg/kg on Day 1 every 3 weeks, and breath pressurized (0.25 MPa) 100% oxygen (O2) indirectly by a head hood or mask for 60 minutes in multiplace chambers at Day 1 of every week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects volunteer to participate in the study and agree to sign the informed consent with good compliance and follow-up.
- Subjects are 18 years old or older when signing the informed consent and gender is not limited.
- Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
- Failed or intolerable to at least one prior systemic treatment for advanced HCC
- With at least one assessment lesion according to the RESIST v1.1 criteria.
Key exclusion criteria (32 listed)
- Subjects with one or more than one of the following criteria should be excluded
- Subjects has contraindications of hyperbaric oxygen use, including pneumothorax, mediastinal edema, multiple rib fractures, open trauma of chest wall, vacuolar pulmonary tuberculosis with hemoptysis, pulmonary bullae, active internal bleeding and hemorrhagic diseases;
- Subjects with other malignant tumors in the past 5 years (radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection of carcinoma in situ were not included);
- subjects are currently participating in other interventional clinical studies, or received any topical treatment within 4 weeks prior to the study, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection;
- systemic treatment with traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration;
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 |
|---|---|---|
| hyperbaric oxygen therapy plus CamrelizumabCamrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody | Combination product | Hyperbaric oxygen therapy plus Camrelizumab |
Primary outcome
Objective Response Rate (ORR) per RECIST v1.1
Time frame: up to 12 months.
ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.
Progression-free survival based on RECIST v1.1
Time frame: Time from first treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.
4 secondary outcomes
Duration of Response Rate per RECIST v1.1
Time frame: up to 12 months
Disease control rate per RECIST v1.1
Time frame: up to 12 months
Overall Survival
Time frame: up to 12 months
Number of Subjects with one or more adverse events as assessed by CTCAE 5.0
Time frame: From screening through 30-35 days after end of treatment, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
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 hyperbaric oxygen therapy plus Camrelizumab in people with Combinational Immunotherapy and Hepatocellular Carcinoma Non-Resectable, run by Zhang Bi Xiang, MD 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 18 inclusion and 32 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 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ze-yang Ding, M.D. (+86-13407156200, dingzyang@sina.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) per RECIST v1.1 (time frame: up to 12 months.). The study lists 2 primary outcomes in all. 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 19 Dec 2023.