Hepatocellular CarcinomaPhase 2NCT05171309
Camrelizumab in Combination With Apatinib Plus NK Cell for Advanced HCC
A Phase 2 study testing Apatinib, Camrelizumab and NK cell in people with Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in combination with apatinib plus NK cell in patients with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Apatinib, Camrelizumab and NK cell
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 ≤ 70, male or female;
- Clinical or pathologically confirmed BCLC B (tumor numbers ≥ 4) or C stage hepatocellular carcinoma (except intracranial metastasis);
- At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary tumor burden (according to RECIST v1.1, the long diameter of spiral CT scan of the measurable lesion is ≥ 10 mm or the short diameter of enlarged lymph nodes is ≥ 15 mm);
- No previous systematic (including systematic study drugs) HCC treatment;
- No contraindications of carrizumab, apatinib and NK cell therapy;
- Patients who have previously received local treatment (such as microwave ablation, radiofrequency ablation, absolute ethanol or acetic acid injection, cryoablation, high intensity focused ultrasound, transcatheter arterial chemoembolization or perfusion chemotherapy, etc.), A. if the focus has not received local treatment before, it can be used as the target focus; b. If the focus has received local treatment before, it can be used as the target focus after the progress is evaluated according to RECIST v1.1 standard;
Show all 15Show fewer
- Child-Pugh score small or equal to 7 points (Child-Pugh A-B);
- Life expectancy of at least 12 weeks;
- ECOG score: 0 to 1 (according to the ECOG score classification);
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up;
- For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be nonlactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Camrelizumab injection.
- The laboratory parameters meets the following requirements (no blood components and cell growth factors are allowed within 14 days before the first dose):
- Absolute neutrophil count ≥ 1.5 × 109 / L; Platelets ≥ 50 × 109 / L; Hemoglobin ≥ 80 g / L; Biochemical examination shall meet the following standards: TBIL < 1.5 × ULN； ALT and AST < 5 × ULN； Bun and Cr ≤ 1 × The clearance rate of ULN or endogenous creatinine ≥ 50ml / min (Cockcroft Gault formula).
- Stable coagulation function: INR ≤ 1.5, PTT < 1.2 times the upper limit of normal value (except for tumor related anticoagulant therapy).
- Anti HBV therapy should be initiated before enrollment for patients with detectable HBV DNA.
Who cannot join
- Accepted any systematic treatment before (excluding traditional Chinese medicine and traditional Chinese medicine preparations);
- Existed Hepatobiliary carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrous lamellar cell carcinoma; Active malignant tumors other than HCC within 5 years or at the same time. Limited localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer in situ, in situ carcinoma of the cervix, and breast cancer in situ, can be included.
- History of organ allograft;
- Moderate and severe ascites with clinical symptoms, i.e. those who need therapeutic puncture and drainage, or child Pugh score > 2 (except those who only show a small amount of ascites on imaging but are not accompanied by clinical symptoms); Uncontrolled or moderate pleural effusion and pericardial effusion;
- With a history of gastrointestinal bleeding or definite tendency of gastrointestinal bleeding within 6 months before enrollment, such as bleeding risk or severe esophageal and gastric varices, local active gastrointestinal ulcer lesions, and positive continuous fecal occult blood, shall not be included in the group (if fecal occult blood is positive in the baseline period, it can be rechecked. If it is still positive after recheck, gastroduodenoscopy is required (EGD), if EGD indicates the risk of bleeding, esophageal and gastric varices cannot be included in the group);
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study drug;
Show all 30Show fewer
- Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Aspirin (> 325 mg / day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol were currently or recently used (within 10 days before the start of study treatment);
- hrombosis or embolism events occurred within 6 months before the start of the study drug, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), pulmonary embolism, etc;
- Suffering heart diseases with clinical symptoms or those not well controlled, such as: (1) heart failure in NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction occurred within 1 year; (4) clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Tc > 450ms (male); QTc > 470ms (female);
- Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥90 mmHg);
- Major vascular diseases (e.g., aortic aneurysms requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months before the start of the study drug;
- Severe, unhealed or cracked wounds and active ulcers or untreated fractures;
- Major surgical treatment (except diagnosis) within 4 weeks before the start of study treatment or major surgical treatment is expected during the study period;
- Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption;
- Clinical signs or symptoms of intestinal obstruction and / or gastrointestinal obstruction within 6 months before the start of study treatment, including incomplete obstruction related to original disease or requiring routine parenteral hydration, parenteral nutrition or tube feeding:
- At the initial diagnosis, patients with incomplete obstruction / obstruction syndrome / signs / symptoms of intestinal obstruction may be admitted to the study if they receive definite (surgical) treatment to subside the symptoms;
- There is evidence of intraabdominal pneumatosis that cannot be explained by puncture or recent surgery;
- Known central nervous system tumors including metastatic brain disease;
- Metastatic diseases involving major airways or blood vessels (such as portal vein trunk or vena cava completely occluded due to tumor invasion, which refers to the confluence of splenic vein and superior mesenteric vein and the branches of hepatic portal vein divided into left and right branches) or large mediastinal tumor mass in the center (less than 30 mm from the ridge);
- With a history of hepatic encephalopathy;
- Present with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormone treatment, or other pulmonary fibrosis, organic pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia or chest computed tomography in the screening period that may interfere with the judgment and treatment of immune-related pulmonary toxicity (CT) subjects with evidence of active pneumonia or severely impaired pulmonary function on the figure, allowed radiation field to have radiation pneumonia; active tuberculosis;
- The patient has any active auto-immune disease or a history of autoimmune disease;
- immunosuppressive treatment with immunosuppressants or systemic hormones within 14 days before the start of study treatment (dose > 10mg / day prednisone or other equivalent hormones);
- Applying strong CYP3A4 / CYP2C19 inducers including rifampicin (and its analogues) and Hypericum perforatum or strong CYP3A4 / CYP2C19 inhibitors within 14 days before the start of study treatment;
- Severe infection within 4 weeks before the start of study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; oral or intravenous administration of therapeutic antibiotics within 2 weeks before the start of study treatment (patients receiving prophylactic antibiotics (e.g. prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible to participate in the study);
- Known history of HIV;
- Co-infection of hepatitis B and HCV.
- Patients have previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or have received apatinib before;
- Palliative radiotherapy for non target lesions allowed to control symptoms must be completed at least 2 weeks before the start of study treatment, and the adverse events caused by radiotherapy have not recovered to ≤ CTCAE level 1.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Guosheng Yuan, PhD, 86-20-62787430, guoshengyuan1991@163.com
Jinzhang Chen, MD
About this study
Official title: Camrelizumab in Combination With Apatinib Plus NK Cell in Patients With Advanced Hepatocellular Carcinoma (CAN): A First-line, Phase-II, Single-arm Trial
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in combination with apatinib plus NK cell in patients with advanced hepatocellular carcinoma.
Read the detailed description
The IMbrave150 study has demonstrated a new regimen to be superior to sorafenib by reducing 42% of death risk, making "T+A" strategy to be the first-line treatment for patients with advanced HCC. Meanwhile, the RESCUE research showed that combined camrelizumab with apatinib has promising objective response rate (ORR=34.3%) and disease control rate (DCR=77.1%) in advanced HCC patients as first-line treatment. Nevertheless, the above researches both show only a fraction of patients benefits from the anti-PD-1/PD-L1 in combination with antiangiogenic therapy. Therefore, it's urgently needed to explore better combinational strategies with other treatments to enhance the efficacy of anti-PD-1 in combination with antiangiogenic therapy. Recently, Pembrolizumab plus allogeneic NK cells have been proved to be effective in advanced non-small cell lung cancer patients. However, there is no study available now analyzing the efficacy and safety of Camrelizumab in combination with apatinib plus NK cell in patients with advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Apatinib, Camrelizumab, NK cell
- Keywords
- Hepatocellular carcinoma, Camrelizumab, Apatinib, NK cell
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
250 mg once daily (QD) oral dosing.
CamrelizumabDrug
200 mg intravenously every 2 weeks.
NK cellDrug
Cord blood derived NK cells 4 cycles, one cycle is defined as: total cells ≥1×109 per time, continuous intravenous infusion for 2 days every 14±2 days
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab in combination with apatinib plus NK cell | Experimental | Drug: Apatinib 250 mg once daily (QD) oral dosing.
Other Names:
• Apatinib Drug: Camrelizumab 200 mg intravenously every 2 weeks.
Other Names:
• Camrelizumab Drug: NK cell Cord blood derived NK cells 4 cycles, one cycle is defined as: total cells ≥1×109 per time, continuous intravenous infusion for 2 days every 14±2 days Receives: Drug: Apatinib; Drug: Camrelizumab; Drug: NK cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1
Measured: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
Secondary outcomes (6)
The disease control rate (DCR)
DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1
Measured: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
The median progression free survival time (mPFS)
The progression free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1
Measured: From date of first dose of study drug to the date of first documentation of disease progression (up to approximately 3 years)
The median overall survival time (mOS)
OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.
Measured: From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)
Progression free survival rate at 12 months
The progression free survival time defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1
Measured: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
Overall survival rate at 12 months
OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.
Measured: From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety will be evaluated according to the NCI CTCAE Version 5.0. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Measured: From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinzhang Chen, MD., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171309
- Sponsor's protocol ID
- NFEC-2021-372
- Status last verified
- Nov 2021
- First submitted
- 26 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uong TNT, Yoon M, Chung IJ, Nam TK, Ahn SJ, Jeong JU, Song JY, Kim YH, Nguyen HPQ, Cho D, Chu TH, Dang GC, Nguyen NPNM. Direct Tumor Irradiation Potentiates Adoptive NK Cell Targeting Against Parental and Stemlike Cancer in Human Liver Cancer Models. Int J Radiat Oncol Biol Phys. 2024 May 1;119(1):234-250. doi: 10.1016/j.ijrobp.2023.11.023. Epub 2023 Nov 21.
PubMed 37981041
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab in Combination With Apatinib Plus NK Cell in Patients With Advanced Hepatocellular Carcinoma (CAN): A First-line, Phase-II, Single-arm Trial
- ClinicalTrials.gov ID
- NCT05171309
- Acronym / sponsor ID
- NFEC-2021-372
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Camrelizumab, Apatinib, NK cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Dec 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 evaluate the efficacy and safety of Camrelizumab in combination with apatinib plus NK cell in patients with advanced hepatocellular carcinoma.
Detailed description
The IMbrave150 study has demonstrated a new regimen to be superior to sorafenib by reducing 42% of death risk, making "T+A" strategy to be the first-line treatment for patients with advanced HCC. Meanwhile, the RESCUE research showed that combined camrelizumab with apatinib has promising objective response rate (ORR=34.3%) and disease control rate (DCR=77.1%) in advanced HCC patients as first-line treatment. Nevertheless, the above researches both show only a fraction of patients benefits from the anti-PD-1/PD-L1 in combination with antiangiogenic therapy. Therefore, it's urgently needed to explore better combinational strategies with other treatments to enhance the efficacy of anti-PD-1 in combination with antiangiogenic therapy. Recently, Pembrolizumab plus allogeneic NK cells have been proved to be effective in advanced non-small cell lung cancer patients. However, there is no study available now analyzing the efficacy and safety of Camrelizumab in combination with apatinib plus NK cell in patients with advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab in combination with apatinib plus NK cell | Experimental | Drug: Apatinib, Drug: Camrelizumab, Drug: NK cellDrug: Apatinib 250 mg once daily (QD) oral dosing. Other Names: • Apatinib Drug: Camrelizumab 200 mg intravenously every 2 weeks. Other Names: • Camrelizumab Drug: NK cell Cord blood derived NK cells 4 cycles, one cycle is defined as: total cells ≥1×109 per time, continuous intravenous infusion for 2 days every 14±2 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 ≤ 70, male or female;
- Clinical or pathologically confirmed BCLC B (tumor numbers ≥ 4) or C stage hepatocellular carcinoma (except intracranial metastasis);
- At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary tumor burden (according to RECIST v1.1, the long diameter of spiral CT scan of the measurable lesion is ≥ 10 mm or the short diameter of enlarged lymph nodes is ≥ 15 mm);
- No previous systematic (including systematic study drugs) HCC treatment;
- No contraindications of carrizumab, apatinib and NK cell therapy;
Key exclusion criteria (30 listed)
- Accepted any systematic treatment before (excluding traditional Chinese medicine and traditional Chinese medicine preparations);
- Existed Hepatobiliary carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrous lamellar cell carcinoma; Active malignant tumors other than HCC within 5 years or at the same time. Limited localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer in situ, in situ carcinoma of the cervix, and breast cancer in situ, can be included.
- History of organ allograft;
- Moderate and severe ascites with clinical symptoms, i.e. those who need therapeutic puncture and drainage, or child Pugh score > 2 (except those who only show a small amount of ascites on imaging but are not accompanied by clinical symptoms); Uncontrolled or moderate pleural effusion and pericardial effusion;
- With a history of gastrointestinal bleeding or definite tendency of gastrointestinal bleeding within 6 months before enrollment, such as bleeding risk or severe esophageal and gastric varices, local active gastrointestinal ulcer lesions, and positive continuous fecal occult blood, shall not be included in the group (if fecal occult blood is positive in the baseline period, it can be rechecked. If it is still positive after recheck, gastroduodenoscopy is required (EGD), if EGD indicates the risk of bleeding, esophageal and gastric varices cannot be included in the group);
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 |
|---|---|---|
| Apatinib250 mg once daily (QD) oral dosing. | Drug | Camrelizumab in combination with apatinib plus NK cell |
| Camrelizumab200 mg intravenously every 2 weeks. | Drug | Camrelizumab in combination with apatinib plus NK cell |
| NK cellCord blood derived NK cells 4 cycles, one cycle is defined as: total cells ≥1×109 per time, continuous intravenous infusion for 2 days every 14±2 days | Drug | Camrelizumab in combination with apatinib plus NK cell |
Primary outcome
Objective response rate (ORR)
Time frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1
6 secondary outcomes
The disease control rate (DCR)
Time frame: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
The median progression free survival time (mPFS)
Time frame: From date of first dose of study drug to the date of first documentation of disease progression (up to approximately 3 years)
The median overall survival time (mOS)
Time frame: From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)
Progression free survival rate at 12 months
Time frame: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
Overall survival rate at 12 months
Time frame: From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Derived from this study: PubMed 37981041Uong TNT, Yoon M, Chung IJ, Nam TK, Ahn SJ, Jeong JU, Song JY, Kim YH, Nguyen HPQ, Cho D, Chu TH, Dang GC, Nguyen NPNM. Direct Tumor Irradiation Potentiates Adoptive NK Cell Targeting Against Parental and Stemlike Cancer in Human Liver Cancer Models. Int J Radiat Oncol Biol Phys. 2024 May 1;119(1):234-250. doi: 10.1016/j.ijrobp.2023.11.023. Epub 2023 Nov 21.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Jinzhang Chen, MD. principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib, Camrelizumab and NK cell in people with Hepatocellular Carcinoma, run by Nanfang Hospital, Southern 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 15 inclusion and 30 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 28 Dec 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 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 Guosheng Yuan, PhD. (86-20-62787430, guoshengyuan1991@163.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: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 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 NCT05171309, 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 28 Dec 2021.