ICCPhase 2NCT04398927
Systemic Chemotherapy Plus PD-1 for Metastasis ICC
A Phase 2 study testing Folfirinox and Sintilimab in people with ICC and Metastatic Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study were designed to verify the better method of survival for metastatic ICC. Since the traditional method for metastatic ICC was GEMOX(recommended from NCCN guideline), our previous study found better results from Folfirinox over GEMOX. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ICC, Metastatic Cancer
- What is being tested?
- Folfirinox and Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 Feb 2021
- 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
- The diagnosis of ICC
- With distant metastasis
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- With no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment
- The following laboratory parameters:
- Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Who cannot join
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil Plus PD-1 for Metastasis ICC-single Arm Prospective Study
This study were designed to verify the better method of survival for metastatic ICC.
Since the traditional method for metastatic ICC was GEMOX(recommended from NCCN guideline), our previous study found better results from Folfirinox over GEMOX.
Our current study were conducted for further investigation to verify the better method for metastatic ICC.
Read the detailed description
ICC(Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX(Systemic Chemotheray) and clinical trials. Our previous study has demonstrate Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) has a survival and tumor response advantage of GEMOX.
Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) plus PD1(Sintilimab).
The progression free survival and overall survival were our primary and secondary endpoint.
Our study were designed to verify the better method of survival for metastatic ICC.
- Conditions
- ICC, Metastatic Cancer
- Being tested
- Folfirinox, Sintilimab
- Keywords
- ICC, metastasis
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FolfirinoxDrug
Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)
SintilimabDrug
Sintilimab
| Study group | Role | What they receive |
|---|---|---|
| Folfirinox plus PD1 | Experimental | Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1 Receives: Drug: Folfirinox; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate of 6 months
Ratio of patients observed progression of tumor at 6 months
Measured: 6 months
Secondary outcomes (2)
Overall survival
Time from enrollment to death for any reason.
Measured: 6 months
Number of adverse events
Postoperative adverse events were graded based on CTCAE v4.03
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 May 2020
- Primary completion1 Jan 2021
- Study completion1 Feb 2021
Why it stopped: no patient enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICCStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
- Investigators
- Ming Shi, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398927
- Sponsor's protocol ID
- S077
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil Plus PD-1 for Metastasis ICC-single Arm Prospective Study
- ClinicalTrials.gov ID
- NCT04398927
- Acronym / sponsor ID
- S077
- Conditions
- ICC, Metastatic Cancer
- Keywords
- ICC, metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 22 May 2020 (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 study were designed to verify the better method of survival for metastatic ICC.
Since the traditional method for metastatic ICC was GEMOX(recommended from NCCN guideline), our previous study found better results from Folfirinox over GEMOX.
Our current study were conducted for further investigation to verify the better method for metastatic ICC.
Detailed description
ICC(Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX(Systemic Chemotheray) and clinical trials. Our previous study has demonstrate Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) has a survival and tumor response advantage of GEMOX.
Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) plus PD1(Sintilimab).
The progression free survival and overall survival were our primary and secondary endpoint.
Our study were designed to verify the better method of survival for metastatic ICC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Folfirinox plus PD1 | Experimental | Drug: Folfirinox, Drug: SintilimabPatients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The diagnosis of ICC
- With distant metastasis
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- With no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
Key exclusion criteria (7 listed)
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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 |
|---|---|---|
| FolfirinoxSystemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan) | Drug | Folfirinox plus PD1 |
| SintilimabSintilimab | Drug | Folfirinox plus PD1 |
Primary outcome
Progression free survival rate of 6 months
Time frame: 6 months
Ratio of patients observed progression of tumor at 6 months
2 secondary outcomes
Overall survival
Time frame: 6 months
Number of adverse events
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Related trials for ICC
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
RecruitingPhase 2
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Metastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc)
RecruitingObservational study
Inter-Device Concordance of Plantar Thermal Asymmetry Measurement (HIK-DM-2026)
Diabetes Mellitus
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.
Ming Shi principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Folfirinox and Sintilimab in people with ICC and Metastatic Cancer, run by Sun Yat-sen 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 8 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: withdrawn, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression free survival rate of 6 months (time frame: 6 months). 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 4 Feb 2021.