Intrahepatic CholangiocarcinomaPhase 2NCT05535647
Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma
A Phase 2 study testing Regorafenib and HAIC and FOLFOX in people with Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Regorafenib and HAIC and FOLFOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2022to 25 Sep 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated IRB/IEC-approved Informed Consent.
- Cytological or histological diagnosis of locally advanced or metastatic adenocarcinoma of the Intrahepatic Cholangiocarcinoma.
- Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed).
- Age 18-75 years
- Karnofsky Performance Status > 50%
- Estimated life expectancy of at least 3 months.
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- Negative pregnancy test (if female in reproductive years).
- Adequate bone marrow, liver and kidney function: leukocyte > 3500/mm3; absolute neutrophil count (ANC) > 1500/mm3; platelet count > 100000/mm3; hemoglobin > 10 g/dl; creatinine < 1.5 mg/dL; total bilirubin ≤ 1.5 x upper limit of normal range (ULN); SGOT e SGPT ≤ 2.5 ULN
- At the time of start of treatment, at least 2 weeks must have elapsed since completion of prior chemotherapy, minor surgery and radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated).
- Resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 4.03) grade ≤ 1 for hematologic toxicities and ≤ 2 for non hematologic toxicities, with the exception of alopecia.
- Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol.
Who cannot join
- History of cardiac disease
- Ongoing infection > Grade 2 according to NCI-CTCAE version 4.03. Hepatitis B is allowed if no active replication (defined as abnormal ALT >2xULN associated with HBV DNA >20,000 IU/mL) is present
- Severe co-morbid illness and/or active infections including active hepatitis C and human immunodeficiency virus (HIV) infection
- History of interstitial lung disease (ILD).
- Any cancer curatively treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1).
- Renal failure requiring hemo- or peritoneal dialysis.
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- Clinically significant GI bleeding (CTCAE 4.03 grade 3 or higher) within 30 days prior to start of screening
- Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of screening.
- History of organ allograft, cornea transplantation will be allowed
- Active CNS metastases not controllable with radiotherapy or corticosteroids Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR.
- Known history of hypersensitivity to study drugs
- Non-healing wound, ulcer, or bone fracture.
- Patients with seizure disorder requiring medication.
- Acute steroid therapy or taper for any purpose (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before start of screening and thereafter).
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Pregnant or lactating women. Women of childbearing potential not employing adequate contraception. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of study treatment and a negative result must be documented before first dose of study drug.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
About this study
Official title: Second Line Therapy With Regorafenib and HAIC Compared to FOLFOX for Advanced Intrahepatic Cholangiocarcinoma
This is a prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma.
Read the detailed description
Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). However,only less than 25% of patients are resectable at diagnosis and, even in this subset of patients, relapse rate is high.
Cisplatin and gemcitabine combination was identified as the standard first-line chemotherapy, yielding a median progression free survival (PFS) and median OS of 8.5 and 11.7 months, respectively. FOLFOX was the standard second-line chemotherapy. But the benefit of FOLFOX was limited.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Regorafenib and HAIC, FOLFOX
- Keywords
- Intrahepatic Cholangiocarcinoma, Regorafenib, HAIC, FOLFOX
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib and HAICDrug
Regorafenib: oral 80mg/day, D1-21, Q28d; HAIC with FOLFOX: hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.
FOLFOXDrug
Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib and HAIC | Experimental | Regorafenib HAIC with FOLFOX Receives: Drug: Regorafenib and HAIC |
| FOLFOX | Active comparator | FOLFOX Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
the rate of complete response and partial response among all evaluable patients
Measured: 12month
Secondary outcomes (4)
Disease control rate (DCR)
the rate of complete response, partial response and stable disease among all evaluable patients
Measured: 12 months
Progression-free Survival (PFS)
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.
Measured: 12 months
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Measured: 24 months
Adverse events (AE)
Adverse events in each cycle were documented based on CTCAE v 4.03
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 posted10 Sep 2022
- Study start25 Sep 2022 (estimated)
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535647
- Sponsor's protocol ID
- E20220698
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Line Therapy With Regorafenib and HAIC Compared to FOLFOX for Advanced Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05535647
- Acronym / sponsor ID
- E20220698
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Intrahepatic Cholangiocarcinoma, Regorafenib, HAIC, FOLFOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 25 Sep 2022 (estimated)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 10 Sep 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 prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma.
Detailed description
Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). However,only less than 25% of patients are resectable at diagnosis and, even in this subset of patients, relapse rate is high.
Cisplatin and gemcitabine combination was identified as the standard first-line chemotherapy, yielding a median progression free survival (PFS) and median OS of 8.5 and 11.7 months, respectively. FOLFOX was the standard second-line chemotherapy. But the benefit of FOLFOX was limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regorafenib and HAIC | Experimental | Drug: Regorafenib and HAICRegorafenib HAIC with FOLFOX |
| FOLFOX | Active comparator | Drug: FOLFOXFOLFOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated IRB/IEC-approved Informed Consent.
- Cytological or histological diagnosis of locally advanced or metastatic adenocarcinoma of the Intrahepatic Cholangiocarcinoma.
- Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed).
- Age 18-75 years
- Karnofsky Performance Status > 50%
Key exclusion criteria (16 listed)
- History of cardiac disease
- Ongoing infection > Grade 2 according to NCI-CTCAE version 4.03. Hepatitis B is allowed if no active replication (defined as abnormal ALT >2xULN associated with HBV DNA >20,000 IU/mL) is present
- Severe co-morbid illness and/or active infections including active hepatitis C and human immunodeficiency virus (HIV) infection
- History of interstitial lung disease (ILD).
- Any cancer curatively treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1).
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 |
|---|---|---|
| Regorafenib and HAICRegorafenib: oral 80mg/day, D1-21, Q28d; HAIC with FOLFOX: hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h. | Drug | Regorafenib and HAIC |
| FOLFOXOxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h. | Drug | FOLFOX |
Primary outcome
Objective response rate (ORR)
Time frame: 12month
the rate of complete response and partial response among all evaluable patients
4 secondary outcomes
Disease control rate (DCR)
Time frame: 12 months
Progression-free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 24 months
Adverse events (AE)
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 10 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Regorafenib and HAIC and FOLFOX in people with Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 16 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 10 Sep 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 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?
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?
Objective response rate (ORR) (time frame: 12month). 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 10 Sep 2022.