ICCNCT06447454
Combining Chemoradiotherapy With Sintilimab in First-Line ICC
An observational study of ICC, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab in the treatment of first-line intrahepatic cholangiocarcinoma patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ICC
- What is being tested?
- radiotherapy, gemcitabine + cisplatin and slulimumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: First-line patients with intrahepatic cholangiocarcinoma
Who may be able to join
- Cholangiocarcinoma confirmed by histology/cytology.
- The included patients were patients with first-line intrahepatic cholangiocarcinoma treated with GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab. All lesions are required to be eligible for RT treatment, and at least one of them is evaluable.
- Liver function Child-Pugh class A, other laboratory tests:
- Neutrophils ≥1.5×109/L； Platelets ≥75×109/L；Hemoglobin ≥90g/L (no blood transfusion record within 2 weeks or no dependence on erythropoietin (EPO))；Serum creatinine ≤1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula)；AST ≤2.5×ULN, ALT ≤2.5×ULN; if intrahepatic lesions are present, ALT and AST ≤5×ULN；TSH, FT3, FT4 within ± 10% of normal values；Coagulation function: international normalized ratio (INR) ≤ 2 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN
- ECOG score 0-1 points.
- Expected survival time > 3 months.
Show all 10Show fewer
- No history of radiation therapy.
- Age ≥18 years old and ≤75 years old.
- Sign the informed consent form and be able to comply with the visits and related procedures stipulated in the plan.
- Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age must take effective contraceptive measures during the entire treatment period and for 6 months after the treatment period.
Who cannot join
- Histology includes components such as hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, and sarcomatoid hepatocellular carcinoma.
- Have a history of hepatic encephalopathy or liver transplantation.
- Pleural effusion, ascites, and pericardial effusion with clinical symptoms or needing drainage, only imaging shows a small amount of pleural effusion, ascites, and pericardial effusion and are asymptomatic and can be selected.
- People with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA>103 copies/ml; hepatitis B Surface antigen (HbsAg) and anti-HCV antibodies were positive at the same time.
- Symptomatic central nervous system metastasis. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases can participate in this study as long as they meet all the following criteria: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Bulbar or spinal cord metastases; maintain clinical stability for at least 4 weeks; discontinue glucocorticoid therapy two weeks before the first dose of study drug.
- History of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease, or extensive intestinal resection (partial colectomy or extensive small bowel resection) within the past 6 months , complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
Show all 19Show fewer
- History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia. Radiation pneumonitis within the radiation treatment area is permitted.
- Active tuberculosis (TB), currently receiving anti-tuberculosis treatment or those who have received anti-tuberculosis treatment within 1 year before the first dose.
- People infected with human immunodeficiency virus (HIV) (HIV 1/2 antibody positive).
- Severe infection in active stage or with poor clinical control. Severe infection within 4 weeks before first dose, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia.
- Active autoimmune diseases that require systemic treatment or a history of the disease within the past 2 years (vitiligo, psoriasis, alopecia or Grave's disease that does not require systemic treatment within the past 2 years, only thyroid hormone is required Patients with hypothyroidism requiring replacement therapy and patients with type I diabetes requiring only insulin replacement therapy are eligible). Known history of primary immunodeficiency. Patients who are only positive for autoimmune antibodies need to confirm whether there is an autoimmune disease according to the researcher's judgment.
- Use of immunosuppressive drugs within the past 4 weeks, excluding topical glucocorticoids by nasal spray, inhalation or other routes or systemic glucocorticoids at physiological doses (i.e. not exceeding 10 mg/day of prednisone or other (other glucocorticoids at effective doses), and the temporary use of glucocorticoids for the treatment of dyspnea symptoms in diseases such as asthma and chronic obstructive pulmonary disease is allowed.
- Have received live attenuated vaccines within the past 4 weeks or plan to during the study period.
- Have received systemic immunostimulant treatment within the past 4 weeks.
- Received major surgical surgery (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within the past 4 weeks.
- Uncontrolled metabolic disorders or other non-malignant tumor organs or systemic diseases or secondary reactions to cancer, which may lead to higher medical risks and/or uncertainty in survival evaluation.
- Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory test values that may increase the risks associated with study participation or administration of study drugs, or interfere with the interpretation of study results, and which, at the discretion of the investigator, may cause the patient to were listed as ineligible to participate in this study.
- Other malignant tumors diagnosed within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or radically resected carcinoma in situ. If other malignant tumors or liver cancer are diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent and metastatic lesions is required.
- Pregnant or breastfeeding female patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital
Shanghai, 200032
Shisuo Du, +86 136 2183 0381, du.shisuo@zs-hospital.sh.cn
Shisuo Du
About this study
Official title: Chemoradiotherapy Combined With Slulimumab in the Treatment of First-line Intrahepatic Cholangiocarcinoma: Efficacy and Safety Evaluation of a Phase II Clinical Study
To evaluate the effectiveness and safety of GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab in the treatment of first-line intrahepatic cholangiocarcinoma patients
- Conditions
- ICC
- Being tested
- radiotherapy, gemcitabine + cisplatin, slulimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Also called RT
radiotherapy
gemcitabine + cisplatinDrug
Also called GC
Gemcitabine 1000mg/m² intravenous infusion over 30 minutes, cisplatin 25mg/m² intravenous infusion, on day 1 and day 8, every 3 weeks.
slulimumabDrug
Also called HLX10
Slulimumab, 4.5mg/kg intravenous infusion, Q3W
| Study group | Role | What they receive |
|---|---|---|
| GC (gemcitabine + cisplatin) + radiotherapy + slulimumab Group | First-line treatment for patients with intrahepatic bile duct carcinoma involves the administration of GC (gemcitabine plus cisplatin) along with radiotherapy and sintilimab. Receives: Radiation: radiotherapy; Drug: gemcitabine + cisplatin; Drug: slulimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
The time from the date of first treatment to disease progression or death, whichever occurs first.
Measured: 2 years
Secondary outcomes (4)
Time-To-Progression
The time from the date of first treatment to any recorded imaging tumor progression.
Measured: 2 years
Objective Response Rate
The use of RECIST version 1.1 standards to evaluate the objective efficacy of tumors, including cases of CR and PR.
Measured: 2 years
Disease Control Rate
The percentage of CR, PR and SD (≥4 weeks) cases among patients whose efficacy can be evaluated.
Measured: 2 years
Incidence of Adverse events
AEs and SAEs, drug-related AEs and SAEs.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Shanghai Zhongshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shisuo Du, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447454
- Sponsor's protocol ID
- zs-ICC-RT+GC+HLX10
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared with other researchers in order to protect patients' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiotherapy Combined With Slulimumab in the Treatment of First-line Intrahepatic Cholangiocarcinoma: Efficacy and Safety Evaluation of a Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06447454
- Acronym / sponsor ID
- zs-ICC-RT+GC+HLX10
- Conditions
- ICC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Jun 2024 (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.
To evaluate the effectiveness and safety of GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab in the treatment of first-line intrahepatic cholangiocarcinoma patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC (gemcitabine + cisplatin) + radiotherapy + slulimumab Group | – | Radiation: radiotherapy, Drug: gemcitabine + cisplatin, Drug: slulimumabFirst-line treatment for patients with intrahepatic bile duct carcinoma involves the administration of GC (gemcitabine plus cisplatin) along with radiotherapy and sintilimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First-line patients with intrahepatic cholangiocarcinoma
Key inclusion criteria (10 listed)
- Cholangiocarcinoma confirmed by histology/cytology.
- The included patients were patients with first-line intrahepatic cholangiocarcinoma treated with GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab. All lesions are required to be eligible for RT treatment, and at least one of them is evaluable.
- Liver function Child-Pugh class A, other laboratory tests:
- Neutrophils ≥1.5×109/L； Platelets ≥75×109/L；Hemoglobin ≥90g/L (no blood transfusion record within 2 weeks or no dependence on erythropoietin (EPO))；Serum creatinine ≤1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula)；AST ≤2.5×ULN, ALT ≤2.5×ULN; if intrahepatic lesions are present, ALT and AST ≤5×ULN；TSH, FT3, FT4 within ± 10% of normal values；Coagulation function: international normalized ratio (INR) ≤ 2 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN
- ECOG score 0-1 points.
Key exclusion criteria (19 listed)
- Histology includes components such as hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, and sarcomatoid hepatocellular carcinoma.
- Have a history of hepatic encephalopathy or liver transplantation.
- Pleural effusion, ascites, and pericardial effusion with clinical symptoms or needing drainage, only imaging shows a small amount of pleural effusion, ascites, and pericardial effusion and are asymptomatic and can be selected.
- People with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA>103 copies/ml; hepatitis B Surface antigen (HbsAg) and anti-HCV antibodies were positive at the same time.
- Symptomatic central nervous system metastasis. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases can participate in this study as long as they meet all the following criteria: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Bulbar or spinal cord metastases; maintain clinical stability for at least 4 weeks; discontinue glucocorticoid therapy two weeks before the first dose of study drug.
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 |
|---|---|---|
| radiotherapyAlso: RTradiotherapy | Radiation | GC (gemcitabine + cisplatin) + radiotherapy + slulimumab Group |
| gemcitabine + cisplatinAlso: GCGemcitabine 1000mg/m² intravenous infusion over 30 minutes, cisplatin 25mg/m² intravenous infusion, on day 1 and day 8, every 3 weeks. | Drug | GC (gemcitabine + cisplatin) + radiotherapy + slulimumab Group |
| slulimumabAlso: HLX10Slulimumab, 4.5mg/kg intravenous infusion, Q3W | Drug | GC (gemcitabine + cisplatin) + radiotherapy + slulimumab Group |
Primary outcome
Progression-free survival(PFS)
Time frame: 2 years
The time from the date of first treatment to disease progression or death, whichever occurs first.
4 secondary outcomes
Time-To-Progression
Time frame: 2 years
Objective Response Rate
Time frame: 2 years
Disease Control Rate
Time frame: 2 years
Incidence of Adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No. The IPD will not be shared with other researchers in order to protect patients' privacy.
Related trials for ICC
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
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
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.
Shisuo Du 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?
An observational study of ICC, run by Shanghai Zhongshan 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 10 inclusion and 19 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: opening soon, as of the sponsor's last update on 7 Jun 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shisuo Du (+86 136 2183 0381, du.shisuo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 2 years). 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 7 Jun 2024.