Metastatic Liver CancerPhase 1NCT05643417
Camrelizumab Combined With Bevacizumab and HAIC in Patients With Metastatic Liver Cancer Who Failed Standard Therapy
A Phase 1 study testing HAIC、Bevacizumab、Camrelizumab in people with Metastatic Liver Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a single center, multi-cohort, phase I basket trial to evaluate the safety and efficacy of camrelizumab in combination with bevacizumab and HAIC for metastatic liver cancer after standard treatment failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Liver Cancer
- What is being tested?
- HAIC、Bevacizumab、Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2022to Oct 2024
- 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
- Informed consent has been signed
- Age ≥ 18 years old
- Liver metastases of solid tumors confirmed by histology or cytology (including but not limited to gastric cancer, breast cancer, lung cancer, nasopharyngeal cancer, thyroid cancer, melanoma, stromal tumor, sarcoma, etc.), including liver metastases at the time of diagnosis or liver metastases occurred after radical resection, and the primary tumor has been resected
- The investigator assessed that the liver metastasis could not be removed surgically
- Progression or intolerance after receiving standard systemic therapy (patients who have received first-line immunotherapy can still be enrolled)
- Child-Pugh score ≤ 7
Show all 11Show fewer
- At least one measurable lesion (according to RECIST 1.1)
- Expected overall survival ≥ 3 months
- ECOG PS score: 0~1
- Has sufficient organ function within 14 days before the first administration, (1) Blood routine: WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥50×109/L; HGB≥90 g/L (2) Liver function: AST≤5.0×ULN; ALT≤5.0×ULN; TBIL≤2.0×ULN (3) Renal function: Cr≤1.5×ULN or CrCl ≥60 mL/min (4) Coagulation function: INR≤1.5; APTT≤1.5×ULN (5) HBV-DNA≤2×103 IU/ml (subjects with HBV-DNA>2×103 IU/ml can be enrolled and should receive antiviral treatment at the same time)
- Women of childbearing age must take contraceptive measures within 3 months from the first dose to the last use of the study drug
Who cannot join
- Patients had other malignant tumors in the past or at the same time (excluding non melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer after treatment)
- Patients had a history of organ transplantation or hepatic encephalopathy
- Suffering from immunodeficiency disease within 7 days before the first administration, or receiving systemic hormone treatment (≥ 10mg/day prednisone or equivalent dose of other hormones), or other forms of immunosuppressive treatment
- Patients who are seriously allergic to iodized contrast agents, antibody drugs, calcium folinate, 5-FU, platinum drugs , (≥ grade 3)
- Participated in other clinical trials or received other test drugs within 4 weeks before the first administration
- Pregnant or lactating women or women of childbearing age are positive in the baseline pregnancy test
- Other factors that may affect the subject's safety or test compliance as judged by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200062
About this study
Official title: A Single Center, Multi Cohort, Phase I Basket Trial of the Safety and Efficacy of Camrelizumab in Combination With Bevacizumab and HAIC for Metastatic Liver Cancer After Standard Treatment Failure
This is a single center, multi-cohort, phase I basket trial to evaluate the safety and efficacy of camrelizumab in combination with bevacizumab and HAIC for metastatic liver cancer after standard treatment failure
Read the detailed description
For patients with advanced primary liver cancer, immunotherapy combined anti-angiogenic therapy has gradually become the first-line standard treatment. However, for metastatic liver cancer, especially after first-line treatment failure, the current treatment options are mostly systemic chemotherapy, and there is still a lack of effective treatment methods. Compared with systemic chemotherapy, HAIC has a higher objective response rate and survival rate, and the incidence of adverse reactions is lower. At the same time, PD-1 combined with chemotherapy has become the first-line standard treatment for many cancers; referring to the expert consensus on liver metastasis of solid tumors and ongoing clinical research, the "PD-1 + anti-angiogenesis + HAIC" regimen can be used as a new research direction for posterior treatment for metastatic liver cancer.
In view of the failure of first-line chemotherapy, how to find effective chemotherapy drugs has become a top priority. HAIC guided by genetic testing may be able to screen out effective chemotherapy drugs
This study is an open-label, single-center, multi-cohort, phase I basket trial designed to explore safety and efficacy of "camrelizumab + bevacizumab + HAIC guided by genetic testing" for metastatic liver cancer after standard treatment failure
- Conditions
- Metastatic Liver Cancer
- Being tested
- HAIC、Bevacizumab、Camrelizumab
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC、Bevacizumab、CamrelizumabDrug
Also called Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo
HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Liver metastasis of gastric cancer | Experimental | HAIC: refer to genetic test results，D1； Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of breast cancer | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of lung cancer | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of nasopharyngeal carcinoma | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of thyroid cancer | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of melanoma | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of stromal tumor | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of sarcoma | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
| Liver metastasis of other solid tumor | Experimental | HAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； Receives: Drug: HAIC、Bevacizumab、Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and degree of Adverse Events and Serious Adverse Events
Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
Measured: 24 months
ORR
objective response rate(ORR)，defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: 24 months
Secondary outcomes (3)
DCR
disease control rate(DCR), defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: 24 months
PFS
progression-free survival(PFS), defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: 24 months
OS
overall survival(OS), defined as the time from enrollment to death due to any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Liver CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
- Investigators
- Lu Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643417
- Sponsor's protocol ID
- 22-OBU-SH-CA-II-019
- Status last verified
- Dec 2022
- First submitted
- 20 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Multi Cohort, Phase I Basket Trial of the Safety and Efficacy of Camrelizumab in Combination With Bevacizumab and HAIC for Metastatic Liver Cancer After Standard Treatment Failure
- ClinicalTrials.gov ID
- NCT05643417
- Acronym / sponsor ID
- 22-OBU-SH-CA-II-019
- Conditions
- Metastatic Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 8 Dec 2022 (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 single center, multi-cohort, phase I basket trial to evaluate the safety and efficacy of camrelizumab in combination with bevacizumab and HAIC for metastatic liver cancer after standard treatment failure
Detailed description
For patients with advanced primary liver cancer, immunotherapy combined anti-angiogenic therapy has gradually become the first-line standard treatment. However, for metastatic liver cancer, especially after first-line treatment failure, the current treatment options are mostly systemic chemotherapy, and there is still a lack of effective treatment methods. Compared with systemic chemotherapy, HAIC has a higher objective response rate and survival rate, and the incidence of adverse reactions is lower. At the same time, PD-1 combined with chemotherapy has become the first-line standard treatment for many cancers; referring to the expert consensus on liver metastasis of solid tumors and ongoing clinical research, the "PD-1 + anti-angiogenesis + HAIC" regimen can be used as a new research direction for posterior treatment for metastatic liver cancer.
In view of the failure of first-line chemotherapy, how to find effective chemotherapy drugs has become a top priority. HAIC guided by genetic testing may be able to screen out effective chemotherapy drugs
This study is an open-label, single-center, multi-cohort, phase I basket trial designed to explore safety and efficacy of "camrelizumab + bevacizumab + HAIC guided by genetic testing" for metastatic liver cancer after standard treatment failure
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Liver metastasis of gastric cancer | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1； Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of breast cancer | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of lung cancer | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of nasopharyngeal carcinoma | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of thyroid cancer | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of melanoma | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of stromal tumor | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of sarcoma | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
| Liver metastasis of other solid tumor | Experimental | Drug: HAIC、Bevacizumab、CamrelizumabHAIC: refer to genetic test results，D1；Bevacizumab：7.5mg/Kg, D2, Q3W；Camrelizumab：200mg, D2, Q3W； |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent has been signed
- Age ≥ 18 years old
- Liver metastases of solid tumors confirmed by histology or cytology (including but not limited to gastric cancer, breast cancer, lung cancer, nasopharyngeal cancer, thyroid cancer, melanoma, stromal tumor, sarcoma, etc.), including liver metastases at the time of diagnosis or liver metastases occurred after radical resection, and the primary tumor has been resected
- The investigator assessed that the liver metastasis could not be removed surgically
- Progression or intolerance after receiving standard systemic therapy (patients who have received first-line immunotherapy can still be enrolled)
Key exclusion criteria (7 listed)
- Patients had other malignant tumors in the past or at the same time (excluding non melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer after treatment)
- Patients had a history of organ transplantation or hepatic encephalopathy
- Suffering from immunodeficiency disease within 7 days before the first administration, or receiving systemic hormone treatment (≥ 10mg/day prednisone or equivalent dose of other hormones), or other forms of immunosuppressive treatment
- Patients who are seriously allergic to iodized contrast agents, antibody drugs, calcium folinate, 5-FU, platinum drugs , (≥ grade 3)
- Participated in other clinical trials or received other test drugs within 4 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 |
|---|---|---|
| HAIC、Bevacizumab、CamrelizumabAlso: Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuoHAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W | Drug | Liver metastasis of breast cancer, Liver metastasis of gastric cancer, Liver metastasis of lung cancer, Liver metastasis of melanoma, Liver metastasis of nasopharyngeal carcinoma, Liver metastasis of other solid tumor, Liver metastasis of sarcoma, Liver metastasis of stromal tumor, Liver metastasis of thyroid cancer |
Primary outcome
Incidence and degree of Adverse Events and Serious Adverse Events
Time frame: 24 months
Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
ORR
Time frame: 24 months
objective response rate(ORR)，defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
3 secondary outcomes
DCR
Time frame: 24 months
PFS
Time frame: 24 months
OS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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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.
Lu Wang principal investigator
Fudan University
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 HAIC、Bevacizumab、Camrelizumab in people with Metastatic Liver Cancer, run by Fudan 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 11 inclusion and 7 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 8 Dec 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 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 Li Tan (15800680751, 121176421@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and degree of Adverse Events and Serious Adverse Events (time frame: 24 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 8 Dec 2022.