Hepatocellular CarcinomaPhase 1/2GOINGNCT04170556
Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma (GOING)
A Phase 1/2 study testing Regorafenib and Nivolumab in people with Hepatocellular Carcinoma, run by Fundacion Clinic per a la Recerca Biomédica at 7 sites in Spain.
Trial summary
Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R). 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?
- Regorafenib and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 7 sitesSpain
- Study dates
- 16 Mar 2020to 9 Jul 2024
- Phase
- Phase 1/2
- 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
- Male or female subjects 18 years of age or older.
- Diagnosis of HCC based on histology or non-invasive criteria if the patients are cirrhotic according to AASLD guidelines.
- Adequate liver function
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1.
- Adequate hematologic profile
- Adequate renal function
Show all 20Show fewer
- All but sorafenib-related dermatologic adverse events must be grade I according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Early dermatologic adverse events related to first-line treatment must be resolved before starting regorafenib.
- Patients with Hepatocellular Carcinoma
- Who develop radiological tumor progression on sorafenib treatment within the 2 months of inclusion in the study and either:
- who are candidates to regorafenib treatment according to the definition in the RESORCE trial or
- who tolerated between 200 and 400 mg of sorafenib for at least 30 days and who did not experience adverse events of grade 3 or more (excluding dermatologic adverse events)(Cohort A).
- After discontinuation of atezolizuamab in combination with bevacizumab because of tumor progression or treatment related toxicity (Cohort B). Note that patients should have received at least 2 doses of atezolizumab in combination with bevacizumab.
- All subjects must have at least one measurable lesion by RECIST 1.1 criteria. Lesions previously treated by percutaneous ablation or TACE must not be considered as target lesion, only naïve target lesions.
- Subjects may be non-infected or have active chronic HCV or HBV infection.
- Subjects must consent to perform 2 hepatic or extra-hepatic tumor biopsies, the first one within 4 weeks before starting regorafenib (this biopsy should be performed at least 5-7 days after the last dose of sorafenib and 21 days after the last dose of atezolizumab in combination with bevacizumab) and the second-one before starting the combination phase (regorafenib plus nivolumab) of the study, allowing the acquisition of a tumor sample for performance of correlative studies.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
- Women must not be breastfeeding.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug plus 90 days for a total of 31 weeks post-treatment completion
- Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements.
- WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug plus 5 half-lives of study drug plus 30 days for a total of 23 weeks post treatment completion.
Who cannot join
- Subjects with myocardial infarction in the last year or active ischemic heart disease
- Subjects with any history of clinically meaningful variceal bleeding within the last three months.
- Subjects with severe peripheral arterial disease
- Subjects with cardiac arrhythmia under treatment with drugs different from beta-blockers or digoxin.
- Subjects with clinically meaningful ascites defined as ascites requiring non-pharmacologic intervention within 6 months prior to the first scheduled dose.
- Subjects with any history of encephalopathy within the last 12 months or requirement for medications to prevent or control encephalopathy.
Show all 36Show fewer
- Unfeasibility to fulfill the follow-up schedule
- Co-infection with hepatitis B and C.
- Prior malignancy active within the previous 3 years
- Subjects with any active autoimmune disease or history of known or suspected autoimmune disease
- Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Patients with HIV infection are eligible if :
- They do not have another active viral infection.
- They have received antiretroviral therapy (ART*) for at least 4 weeks prior to randomization, as clinically indicated.
- They continue on ART as clinically indicated while enrolled on study.
- CD4 counts and viral load are monitored per standard of care by a local health care provider.
- () The ART regimen includes drugs that are permitted according to protocol. An evaluation by the infectious disease specialist should be provided to the Medical Monitor (MM) prior to the enrollment.
- Known active drug or alcohol abuse.
- Prior therapy with an anti-PD-1, anti-PD-L1 (other than atezolizumab), anti-PD-L2, anti-CD137, or anti-Cytotoxic T-Lymphocyte Antigen 4 antibody (anti-CTLA-4 antibody)
- Prior monotherapy treatment with any tyrosine kinase inhibitor in first line other than sorafenib.
- Prior organ allograft or allogeneic bone marrow transplantation
- All but dermatologic toxicities attributed to first-line treatment must have resolved to Grade 1 (NCI CTCAE version 5) or baseline before administration of study drug. Subjects with toxicities attributed to first-line treatment therapy that are not expected to resolve and result in long-lasting sequelae are not permitted. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 5). Dermatologic toxicities must be resolved.
- Active bacterial or fungal infections requiring systemic treatment within 7 days.
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.
- Known or underlying medical conditions that, in the Investigator's opinion, would make the administration of the study drug hazardous to the subjects or obscure the interpretation of toxicity determination or adverse events.
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
- Laboratory evidence of any underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
- History of severe hypersensitivity reactions to other monoclonal antibodies or regorafenib.
- History of allergy to study drug components.
- WOCPB who are pregnant or breastfeeding.
- Women with a positive pregnancy test at enrollment or prior to administration of study medication.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
- Inability to comply with restrictions and prohibited activities/treatments.
- Subjects in the Child-Pugh classes B≥7 points or C are not allowed to be recruited into this trial.
- subjects with uncontrolled arterial hypertension.
- Concomitant anticoagulation, at therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, low molecular weight heparin (LMWH), thrombin or coagulation factor X (FXa) inhibitors, or antiplatelet agents (eg, clopidogrel).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Clinic
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Gregorio Marañon
Madrid
Hospital Puerta de Hierro
Madrid
Hospital Ramon y Cajal
Madrid
Hospital Central de Asturias
Oviedo
Clinica Universidad de Navarra
Pamplona
About this study
Official title: The GOING Study: Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma Progressing Under Sorafenib or After Discontinuation of Atezolizumab Plus Bevacizumab
Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R). In particular, regorafenib inhibits mutated KIT, a major oncogenic driver in gastrointestinal stromal tumours, and thereby blocks tumour cell proliferation.
Regorafenib has shown in clinical trials an acceptable benefit-risk across different tumor types, including colorectal cancer (CRC), GastroIntestinal Stromal Tumors (GIST) and HCC.
Read more
The most frequently observed adverse drug reactions (≥30%) in patients receiving regorafenib are pain, hand-foot skin reaction (HFSR), asthenia/fatigue, diarrhea, decreased appetite and food intake, hypertension, and infection.
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody to the programmed death (PD)-1 receptor, blocking the interaction with PD-ligand (PD-L)1/PD-L213 and restoring T-cell-mediated antitumor activity. Nivolumab was evaluated in second-line the CheckMate 040 Study (Escalation and Expansion cohort.
In both cohorts of the CheckMate 040 Study, the safety profile was acceptable and there were no reported nivolumab-related deaths. In the dose-expansion cohorts from the Phase 1/2 CheckMate 040 Study, 65% of patients had treatment-related adverse events (TRAEs) of any grade 18% with Grade 3 or 4 TRAEs with fatigue, pruritus, and rash being the most common. Elevation of aspartate transaminase (AST) and alanine transaminase (ALT) were the most frequent Grade 3-4 TRAEs. AST/ALT elevations, however, were generally asymptomatic and readily managed.
For this reason, the rationale of this Phase I/IIa trial is to optimize the action of regorafenib and nivolumab but bearing in mind the potential impact of the drug-interaction and enhancement of the severity and/or frequency of adverse events. Thus, regorafenib will be administered as monotherapy during the first 2 cycles (each cycle is 3 weeks on plus 1 week off) of treatment to enhance T cell trafficking and infiltration into the tumor bed to increase the benefits of anti-PD-PD-L1, specific stimuli while emitting Damage-associated molecular patterns (DAMPs), followed by regorafenib plus nivolumab to impact step 7 of the cancer immunity cycle described by Chen.
The anti-PD-L1 effect under hypoxia was evaluated by Noman et al in a tumor model and they postulated that the abrogated myeloid-derived suppressor cells (MDSC)-mediated T cell suppression is achieved in part by modulating the cytokine production (IL-6 and IL-10). Specifically, hypoxia could promote immunosuppression by reducing the cytotoxic efficacy of immune cells, by increasing the peri-tumoral immunosuppressive cell populations infiltration of and priming the expression of immunosuppressive cytokines.
Current options for first line are sorafenib and atezolizumab-bevacizumab. Lenvatinib has been shown to be non-inferior to sorafenib, but it is less frequently used and its toxicity profile mandates a stringent selection of patients. Sorafenib shares some molecular targets with regorafenib, but this has specific action against VEGFR-2, VEGFR-3, Tie-2, PDGFR, FGFR-1, c-Kit, RET and p38-alpha7. Both are antiangiogenic as bevacizumab, but while bevacizumab is limited to the VEGF pathway, they act on several additional target involved in cancer progression. Atezolizumab and nivolumab target the PD1 checkpoint but acting at different levels: PD-1 receptor for Nivolumab and PD-L1 for Atezolizumab. This implies a difference and if resistance to one of the antibodies emerges during treatment, the use of the other one may overcome such key event leading to treatment failure. Recently, the combination of tremelimumab and durvalumab improved OS in comparison to sorafenib; in addition, durvalumab monotherapy was not inferior to sorafenib.
The aim of this study is to do a sequential treatment combining regorafenib, second- line treatment in hepatocellular carcinoma (HCC) with anti PD-1 to enhance the outcome of patients based on the synergy between both drugs.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Regorafenib, Nivolumab
- Keywords
- hepatocellular, sorafenib, regorafenib, nivolumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Regorafenib 160 mg/day 3 weeks on and 1 week off
NivolumabDrug
Nivolumab at the dose of 1.5 mg/kg, 3 mg/kg or 240 mg/infusion every 2 weeks. Dose will be adjusted depending on the incidence of adverse events
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib plus Nivolumab | Experimental | Regorafenib will be initiated at full dose (160 mg/day; 3 weeks on and 1 week off) in monotherapy for the first 8 weeks. After week 8, regorafenib will be continued in combination with nivolumab, until symptomatic tumor progression, unacceptable adverse events, patient decision or death Receives: Drug: Regorafenib; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Rate of adverse events (AE)
Measured: Up to 24 months
Incidence of related Treatment-Emergent Adverse Events
Rate of related-AEs
Measured: Up to 24 months
Incidence of Treatment-Emergent Adverse Events
Rate of death
Measured: Up to 24 months
Secondary outcomes (7)
Overall survival (OS)
Time from the date of start of treatment until the date of death
Measured: Up to 24 months
Time to progression (TTP)
Time from the date of start of treatment until the date of objective disease progression or death
Measured: Up to 24 months
Objective response rate (ORR)
Time from the date of start of treatment until the date of objective response
Measured: Up to 24 months
Pattern of progression
Time from the date of start of treatment until the date of objective response
Measured: Up to 24 months
Post-progression survival (PPS)
Time from the date of disease progression until the date of death
Measured: Up to 24 months
Rate of patients who develop new extra-hepatic spread
Time from the date of start of treatment until the date of objective new extra-hepatic progression
Measured: Up to 24 months
Serum and tissue marker characterization
Time from the date of start of treatment until the date of objective disease progression or death
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start16 Mar 2020
- Primary completion9 Jul 2024
- Study completion9 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Regorafenib followed by Nivolumab
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Maria Reig, MD, Principal investigator, BCLC group. Liver Unit. Hospital Clinic. Ciberehd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170556
- Sponsor's protocol ID
- GOING
- Other IDs
- 2019-003108-10, 2019
- Acronym
- GOING
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2019
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GOING Study: Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma Progressing Under Sorafenib or After Discontinuation of Atezolizumab Plus Bevacizumab
- ClinicalTrials.gov ID
- NCT04170556
- Acronym / sponsor ID
- GOING / GOING
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular, sorafenib, regorafenib, nivolumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R). In particular, regorafenib inhibits mutated KIT, a major oncogenic driver in gastrointestinal stromal tumours, and thereby blocks tumour cell proliferation.
Regorafenib has shown in clinical trials an acceptable benefit-risk across different tumor types, including colorectal cancer (CRC), GastroIntestinal Stromal Tumors (GIST) and HCC.
The most frequently observed adverse drug reactions (≥30%) in patients receiving regorafenib are pain, hand-foot skin reaction (HFSR), asthenia/fatigue, diarrhea, decreased appetite and food intake, hypertension, and infection.
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody to the programmed death (PD)-1 receptor, blocking the interaction with PD-ligand (PD-L)1/PD-L213 and restoring T-cell-mediated antitumor activity. Nivolumab was evaluated in second-line the CheckMate 040 Study (Escalation and Expansion cohort.
In both cohorts of the CheckMate 040 Study, the safety profile was acceptable and there were no reported nivolumab-related deaths. In the dose-expansion cohorts from the Phase 1/2 CheckMate 040 Study, 65% of patients had treatment-related adverse events (TRAEs) of any grade 18% with Grade 3 or 4 TRAEs with fatigue, pruritus, and rash being the most common. Elevation of aspartate transaminase (AST) and alanine transaminase (ALT) were the most frequent Grade 3-4 TRAEs. AST/ALT elevations, however, were generally asymptomatic and readily managed.
For this reason, the rationale of this Phase I/IIa trial is to optimize the action of regorafenib and nivolumab but bearing in mind the potential impact of the drug-interaction and enhancement of the severity and/or frequency of adverse events. Thus, regorafenib will be administered as monotherapy during the first 2 cycles (each cycle is 3 weeks on plus 1 week off) of treatment to enhance T cell trafficking and infiltration into the tumor bed to increase the benefits of anti-PD-PD-L1, specific stimuli while emitting Damage-associated molecular patterns (DAMPs), followed by regorafenib plus nivolumab to impact step 7 of the cancer immunity cycle described by Chen.
The anti-PD-L1 effect under hypoxia was evaluated by Noman et al in a tumor model and they postulated that the abrogated myeloid-derived suppressor cells (MDSC)-mediated T cell suppression is achieved in part by modulating the cytokine production (IL-6 and IL-10). Specifically, hypoxia could promote immunosuppression by reducing the cytotoxic efficacy of immune cells, by increasing the peri-tumoral immunosuppressive cell populations infiltration of and priming the expression of immunosuppressive cytokines.
Current options for first line are sorafenib and atezolizumab-bevacizumab. Lenvatinib has been shown to be non-inferior to sorafenib, but it is less frequently used and its toxicity profile mandates a stringent selection of patients. Sorafenib shares some molecular targets with regorafenib, but this has specific action against VEGFR-2, VEGFR-3, Tie-2, PDGFR, FGFR-1, c-Kit, RET and p38-alpha7. Both are antiangiogenic as bevacizumab, but while bevacizumab is limited to the VEGF pathway, they act on several additional target involved in cancer progression. Atezolizumab and nivolumab target the PD1 checkpoint but acting at different levels: PD-1 receptor for Nivolumab and PD-L1 for Atezolizumab. This implies a difference and if resistance to one of the antibodies emerges during treatment, the use of the other one may overcome such key event leading to treatment failure. Recently, the combination of tremelimumab and durvalumab improved OS in comparison to sorafenib; in addition, durvalumab monotherapy was not inferior to sorafenib.
The aim of this study is to do a sequential treatment combining regorafenib, second- line treatment in hepatocellular carcinoma (HCC) with anti PD-1 to enhance the outcome of patients based on the synergy between both drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Regorafenib followed by Nivolumab
| Arm | Type | Receives |
|---|---|---|
| Regorafenib plus Nivolumab | Experimental | Drug: Regorafenib, Drug: NivolumabRegorafenib will be initiated at full dose (160 mg/day; 3 weeks on and 1 week off) in monotherapy for the first 8 weeks. After week 8, regorafenib will be continued in combination with nivolumab, until symptomatic tumor progression, unacceptable adverse events, patient decision or death |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female subjects 18 years of age or older.
- Diagnosis of HCC based on histology or non-invasive criteria if the patients are cirrhotic according to AASLD guidelines.
- Adequate liver function
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1.
- Adequate hematologic profile
Key exclusion criteria (36 listed)
- Subjects with myocardial infarction in the last year or active ischemic heart disease
- Subjects with any history of clinically meaningful variceal bleeding within the last three months.
- Subjects with severe peripheral arterial disease
- Subjects with cardiac arrhythmia under treatment with drugs different from beta-blockers or digoxin.
- Subjects with clinically meaningful ascites defined as ascites requiring non-pharmacologic intervention within 6 months prior to the first scheduled dose.
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 |
|---|---|---|
| RegorafenibRegorafenib 160 mg/day 3 weeks on and 1 week off | Drug | Regorafenib plus Nivolumab |
| NivolumabNivolumab at the dose of 1.5 mg/kg, 3 mg/kg or 240 mg/infusion every 2 weeks. Dose will be adjusted depending on the incidence of adverse events | Drug | Regorafenib plus Nivolumab |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 24 months
Rate of adverse events (AE)
Incidence of related Treatment-Emergent Adverse Events
Time frame: Up to 24 months
Rate of related-AEs
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 24 months
Rate of death
7 secondary outcomes
Overall survival (OS)
Time frame: Up to 24 months
Time to progression (TTP)
Time frame: Up to 24 months
Objective response rate (ORR)
Time frame: Up to 24 months
Pattern of progression
Time frame: Up to 24 months
Post-progression survival (PPS)
Time frame: Up to 24 months
Rate of patients who develop new extra-hepatic spread
Time frame: Up to 24 months
Serum and tissue marker characterization
Time frame: Up to 24 months
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 3 Sep 2024.
- Individual participant dataSharing planned: Undecided
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.
Maria Reig, MD principal investigator
BCLC group. Liver Unit. Hospital Clinic. Ciberehd
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Regorafenib and Nivolumab in people with Hepatocellular Carcinoma, run by Fundacion Clinic per a la Recerca Biomédica at 7 sites in Spain.
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 20 inclusion and 36 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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 combined 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.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 24 months). The study lists 3 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 3 Sep 2024.