Hepatocellular CarcinomaPhase 2CaPtureNCT04767906
Cabozantinib Treatment in a Phase II Study for Patients With Hepatocellular Carcinoma (HCC) Refractory to PD-1 Inhibitors
A Phase 2 study testing Cabozantinib in people with Hepatocellular Carcinoma, run by University of Leipzig at 5 sites in Germany.
Trial summary
The CaPture trial is a prospective, multi-centre, non-randomized phase II study. Its aim is to assess feasibility, safety and efficacy signals of Cabozantinib treatment in patients with HCC and prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesGermany
- Study dates
- 14 Dec 2021to 19 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
- Pre-Treatment with a PD-1/PD-L1 inhibitor for at least one administration which was given as first line or as following line systemic treatment alone or in combination with other systemic or local treatments (e.g. TACE)
- Disease progression or end of therapy due to toxicity during/after pre-therapy
- CTCAE ≤ Grade 2 prior to study registration, with the exception of alopecia
- ECOG (Eastern Cooperative of Onco-logy Group) Index 0 or 1
- Age ≥ 18 years
- Written informed consent
Who cannot join
- Significant portal hypertension (moderate or severe ascites)
- No adequate controlled arterial hypertension (RR > 140/80mmHg)
- ALAT/ASAT five times higher then upper normal value
- Hepatic encephalopathy (every stage)
- Liver cirrhosis Child-Pugh B and C
- Known fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma mixed with HCC
Show all 35Show fewer
- Major surgical procedure, other than for diagnosis, within eight weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- Severe infection with alteration of general condition within four weeks prior to initiation of study treatment
- Severely impaired kidney function (CDK: stadium 4: GFR<30)
- Myocardial infarction within 12 months prior to initiation of study treatment
- Epilepsy
- Heart failure, Cardiac arrhythmia, respectively long-QT syndrome
- Severe bleeding or high risk for the development of severe bleeding, including esophageal varices > 1° or esophageal varices with red marks as seen on a lighted stomach scope (endoscopy)
- Chronic inflammatory bowel disease (e.g. colitis ulcerosa, diverticulitis, Crohn's disease)
- Increased risk of thromboembolism due to medical history or disease
- Significant alcohol consumption (>1 drink/day; 1 drink=0.25l beer or 0,1l wine or 2cl spirituous beverages)
- Known active HIV infection
- Known hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption
- Prior Cabozantinib use
- Ongoing therapy with direct oral anticoagulants (DOAK) / platelet aggregation inhibitor or statine (e.g. Ticagrelor, Clopidogrel)
- Predicted life expectancy of less than 6 months
- Female patients who do not meet at least one of the following criteria:
- Postmenopausal women (for at least 1 year before the screening visit) OR
- Postoperative status (6 weeks after bilateral ovariectomy with or without hysterectomy) OR
- If they are of childbearing potential, agree to practice one highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) OR
- Abstinence OR
- Vasectomy of the partner
- Male patients not using one of the following variants for contraception including a period of 4 months after the completion of the therapy:
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. OR
- Condition after vasectomy OR
- Condom
- Participation in any other interventional trials within 28 days prior to initiation of study treatment
- Suspected lack of compliance to previous treatments; inability to take the medication
- Pregnancy or lactation, or intention of becoming pregnant during study treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Charite Universitätsmedizin, Campus Virchow Klinikum, Klinik für Hepatologie/Gastroenterologie
Berlin, 13353
Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus Medizinische Klinik und Poliklinik I
Dresden, Saxony, 01307
MVZ Mitte/MVZ Delitzsch GmbH
Leipzig, Saxony, 04103
University Hospital Leipzig
Leipzig, Saxony, 04103
Universitätsklinikum Mannheim
Mannheim, 68167
About this study
The CaPture trial is a prospective, multi-centre, non-randomized phase II study. Its aim is to assess feasibility, safety and efficacy signals of Cabozantinib treatment in patients with HCC and prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment. Since the potential study population is very small, the sample size has been fixed in advance to N = 40. Time on treatment (TT) will be measured as primary endpoint.
Read the detailed description
Patients will be recruited at the participating trial sites (up to ten trial sites), which are all specialized in treatment of patients with HCC. Once potential patients are identified by trial physicians, they will be asked for trial participation and informed consent by one investigator of the CaPture trial. Patients included within 4 weeks after diagnosis of failure of preceding PD-1/PD-L1 inhibitory treatment.
After baseline, visits are previewed on a 4weekly (28 days) basis during the whole duration of Cabozantinib study treatment, which can be used for a maximum of 12 months (336 days). The treatment with Cabozantinib will be performed in accordance with the valid license and according to the judgement of the treating physician.The tablet is taken once a day, starting normally with the highest dosage (60 mg). The doses 20mg and 40mg are still available and can be used for dose reduction. During the visits, the patient will be questioned for compliance and side effects and examined for clinical and laboratory parameters.
Response to Cabozantinib should be assessed at least every 12 weeks (84 days) by either CT scan or MRI.
After termination of Cabozantinib study treatment the first follow-up visit takes place one month after the end of therapy in person. Further follow-up visits can be done by phone to collect patient's status and further treatment.
In addition to the time on treatment (TT), survival, response, feasibility, biomarkers, health status and safety should also be tested.
Furthermore there is an concomitant scientific project. The aim of this project is to examinate the association of HCC related biomarkers with response to Cabozantinib in patients treated in the CaPture study. For this, we will analyse liver biopsy samples as well as circulating markers in patients who are willing to participate in the project.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Cabozantinib
- Keywords
- HCC, Cabozantinib, PD-1 inhibitor, PD-L1 inhibitor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
The medication is taken once a day for 336 days (max.). The start dose is 60mg and can be reduced according to the physicians decision. 40mg and 20mg are also available.
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib | Other | Enrolled patients start with 60mg of Cabozantinib. The maximum duration of treatment is 336 days. The dose can be adjusted by the physician to 40mg or 20mg. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
time on treatment (TT)
Primary endpoint of the trial is the time on treatment (TT). TT is defined as one plus the last date of treatment with Cabozantinib minus the first date of treatment with Cabozantinib, and will be measured in days (note that Cabozantinib will be administered as a single dose per day). The end of treatment must be confirmed by the investigator. In particular, planned discontinuations or missing compliance will not be considered as end of treatment without confirmation.
Measured: start of treatment until end of treatment (max. 336 days)
Secondary outcomes (15)
Overall survival (OS)
Overall survival (OS), is the time to death of any cause. OS is measured in days, defined as death date minus registration date.
Measured: screening visit until date of death, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Progression-free survival (PFS)
Progression-free survival (PFS) is the time to tumor progression or death of any cause, whichever comes first. PFS is measured in days, defined as date of diagnosis of tumor progression by mRECIST criteria minus registration date. If a patient dies without previous diagnosis of tumor progression, date of diagnosis is replaced by death date.
Measured: screening visit until the time to tumor progression or date of death from any cause, whichever came first, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Duration of response (DoR)
is the time from achievement of response (i.e., measurement criteria for CR or PR are first met, cf. Eisenhauer et al., 2009, p. 236) until the first date that tumor recurrence or progression is documented (taking as reference the smallest measurements recorded in the study) or death of any cause, whichever comes first. DoR is measured in days, defined as date of documentation of tumor progression by mRECIST criteria minus date of documentation of tumor response (CR or PR). If a patient dies without previous diagnosis of tumor progression, date of progression documentation is to be replaced by death date. If CR or PR will never be documented for a patient, DoR is set to "zero".
Measured: screening visit until the time from achievement of response or date of death from any cause, whichever came first, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Response rates
Response rates, measured in percent, are defined as the number of patients whose best tumor response observed by mRECIST criteria is CR, PR, SD or PD, respectively, divided by the total number of registered patients. The overall response rate (ORR) is defined as the number of patients whose best tumor response observed by mRECIST criteria is CR or PR divided by the total number of registered patients.
Measured: screening visit until end of treatment (max. 336 days)
Median average dose
Median average dose, measured in milligram (mg). Averages of all Cabozantinib doses administered will be calculated weekly from first date of treatment until end of treatment. Discontinuations of treatment for any reason, including missing compliance, will be included into this calculation as zero doses. Median average dose is defined as the median of the obtained sequence of averages.
Measured: start of treatment until end of treatment (max. 336 days)
Image-based endpoint: Tumor progression
Tumor progression, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) in comparison to the state at Screening, by mRECIST criteria.
Measured: screening until end of treatment (max. 336 days)
Image-based endpoint: Progression of tumoral macrovascular invasion
Progression of tumoral macrovascular invasion of hepatic and/or portal vein branches, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) according to the working instruction for radiologists, in comparison to state at Screening.
Measured: screening until end of treatment (max. 336 days)
Image-based endpoint: Progression of extrahepatic HCC manifestations
Progression of extrahepatic HCC manifestations, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) according to the working instruction for radiologists, in comparison to state at Screening.
Measured: screening until end of treatment (max. 336 days)
Image-based endpoint: Total tumor volume
Total tumor volume (TTV), assessed at Screening, Visits 3, 6, 9, 12 and EoT visit (if applicable), measured in cm^3 according to the working instruction for radiologists.
Measured: screening until end of treatment (max. 336 days)
Image-based endpoint: Affection rate
Affection rate, assessed at Screening, Visits 3, 6, 9, 12 and EoT visit (if applicable), measured in percent. Affection rate is defined as total tumor volume divided by total liver volume, both measured in cm^3 according to the working instruction for radiologists.
Measured: screening until end of treatment (max. 336 days)
Concentration of Alpha-fetoprotein (AFP),
Concentration of Alpha-fetoprotein (AFP), measured in µg/l, at Screening and Visits 0, 3, 6, 9, 12 and EoT visit (if applicable).
Measured: screening until end of treatment (max. 336 days)
Child-Pugh classification score
Child-Pugh classification score, measured in levels from A to C, at Screening and Visits 3, 6, 9, 12, EoT and FU1 (if applicable).
Measured: screening until first follow-up (one month after EoT)
ECOG Performance Status
ECOG Performance Status, measured in levels from 0 to 5, at Screening and Visits 3, 6, 9, 12, EoT and FU1 (if applicable).
Measured: screening until first follow-up (one month after EoT)
drug-related interruption, reduction or termination of treatment (safety endpoint)
Descriptive documentation
Measured: start of treatment until end of treatment (max. 336 days)
occurence of clinical symptoms of liver dysfunction (safety endpoint)
Descriptive documentation
Measured: start of treatment until end of treatment (max. 336 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start14 Dec 2021
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with hepatocellular carcinoma with prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment will be treated with Cabozantinib.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian van Bömmel, MD, Study chair, Authorised representative of the sponsor (University of Leipzig)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767906
- Sponsor's protocol ID
- CaPture
- Acronym
- CaPture
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2021
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data underlying published results will be shared after re-identification. This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabozantinib Treatment in a Phase II Study for Patients With Hepatocellular Carcinoma (HCC) Refractory to PD-1 Inhibitors
- ClinicalTrials.gov ID
- NCT04767906
- Acronym / sponsor ID
- CaPture / CaPture
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Cabozantinib, PD-1 inhibitor, PD-L1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 23 Feb 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 CaPture trial is a prospective, multi-centre, non-randomized phase II study. Its aim is to assess feasibility, safety and efficacy signals of Cabozantinib treatment in patients with HCC and prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment. Since the potential study population is very small, the sample size has been fixed in advance to N = 40. Time on treatment (TT) will be measured as primary endpoint.
Detailed description
Patients will be recruited at the participating trial sites (up to ten trial sites), which are all specialized in treatment of patients with HCC. Once potential patients are identified by trial physicians, they will be asked for trial participation and informed consent by one investigator of the CaPture trial. Patients included within 4 weeks after diagnosis of failure of preceding PD-1/PD-L1 inhibitory treatment.
After baseline, visits are previewed on a 4weekly (28 days) basis during the whole duration of Cabozantinib study treatment, which can be used for a maximum of 12 months (336 days). The treatment with Cabozantinib will be performed in accordance with the valid license and according to the judgement of the treating physician.The tablet is taken once a day, starting normally with the highest dosage (60 mg). The doses 20mg and 40mg are still available and can be used for dose reduction. During the visits, the patient will be questioned for compliance and side effects and examined for clinical and laboratory parameters.
Response to Cabozantinib should be assessed at least every 12 weeks (84 days) by either CT scan or MRI.
After termination of Cabozantinib study treatment the first follow-up visit takes place one month after the end of therapy in person. Further follow-up visits can be done by phone to collect patient's status and further treatment.
In addition to the time on treatment (TT), survival, response, feasibility, biomarkers, health status and safety should also be tested.
Furthermore there is an concomitant scientific project. The aim of this project is to examinate the association of HCC related biomarkers with response to Cabozantinib in patients treated in the CaPture study. For this, we will analyse liver biopsy samples as well as circulating markers in patients who are willing to participate in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with hepatocellular carcinoma with prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment will be treated with Cabozantinib.
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib | Other | Drug: CabozantinibEnrolled patients start with 60mg of Cabozantinib. The maximum duration of treatment is 336 days. The dose can be adjusted by the physician to 40mg or 20mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with diagnosis of locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
- Pre-Treatment with a PD-1/PD-L1 inhibitor for at least one administration which was given as first line or as following line systemic treatment alone or in combination with other systemic or local treatments (e.g. TACE)
- Disease progression or end of therapy due to toxicity during/after pre-therapy
- CTCAE ≤ Grade 2 prior to study registration, with the exception of alopecia
- ECOG (Eastern Cooperative of Onco-logy Group) Index 0 or 1
Key exclusion criteria (35 listed)
- Significant portal hypertension (moderate or severe ascites)
- No adequate controlled arterial hypertension (RR > 140/80mmHg)
- ALAT/ASAT five times higher then upper normal value
- Hepatic encephalopathy (every stage)
- Liver cirrhosis Child-Pugh B and C
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 |
|---|---|---|
| CabozantinibThe medication is taken once a day for 336 days (max.). The start dose is 60mg and can be reduced according to the physicians decision. 40mg and 20mg are also available. | Drug | Cabozantinib |
Primary outcome
time on treatment (TT)
Time frame: start of treatment until end of treatment (max. 336 days)
Primary endpoint of the trial is the time on treatment (TT). TT is defined as one plus the last date of treatment with Cabozantinib minus the first date of treatment with Cabozantinib, and will be measured in days (note that Cabozantinib will be administered as a single dose per day). The end of treatment must be confirmed by the investigator. In particular, planned discontinuations or missing compliance will not be considered as end of treatment without confirmation.
15 secondary outcomes
Overall survival (OS)
Time frame: screening visit until date of death, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Progression-free survival (PFS)
Time frame: screening visit until the time to tumor progression or date of death from any cause, whichever came first, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Duration of response (DoR)
Time frame: screening visit until the time from achievement of response or date of death from any cause, whichever came first, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Response rates
Time frame: screening visit until end of treatment (max. 336 days)
Median average dose
Time frame: start of treatment until end of treatment (max. 336 days)
Image-based endpoint: Tumor progression
Time frame: screening until end of treatment (max. 336 days)
Image-based endpoint: Progression of tumoral macrovascular invasion
Time frame: screening until end of treatment (max. 336 days)
Image-based endpoint: Progression of extrahepatic HCC manifestations
Time frame: screening until end of treatment (max. 336 days)
Image-based endpoint: Total tumor volume
Time frame: screening until end of treatment (max. 336 days)
Image-based endpoint: Affection rate
Time frame: screening until end of treatment (max. 336 days)
Concentration of Alpha-fetoprotein (AFP),
Time frame: screening until end of treatment (max. 336 days)
Child-Pugh classification score
Time frame: screening until first follow-up (one month after EoT)
ECOG Performance Status
Time frame: screening until first follow-up (one month after EoT)
drug-related interruption, reduction or termination of treatment (safety endpoint)
Time frame: start of treatment until end of treatment (max. 336 days)
occurence of clinical symptoms of liver dysfunction (safety endpoint)
Time frame: start of treatment until end of treatment (max. 336 days)
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 23 Jan 2025.
- Individual participant dataSharing planned: Yes. After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data underlying published results will be shared after re-identification. This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the meta-analysis.
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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.
Florian van Bömmel, MD study chair
Authorised representative of the sponsor (University of Leipzig)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabozantinib in people with Hepatocellular Carcinoma, run by University of Leipzig at 5 sites in Germany.
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 35 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 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
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?
time on treatment (TT) (time frame: start of treatment until end of treatment (max. 336 days)). 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 23 Jan 2025.