CholangiocarcinomaPhase 2SCRCANCT05207735
PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma.
A Phase 2 study testing Sintilimab in people with Cholangiocarcinoma, run by Henan Cancer Hospital.
Trial summary
This is a single-center, single-arm, prospective phase II clinical study to evaluate the effectiveness and safety of Sintilimab combined with capecitabine in patients after radical resection of cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18-75 years old;
- Sign written informed consent, and be able to comply with the visits and related procedures stipulated in the plan;
- Histopathological diagnosis was extrahepatic cholangiocarcinoma, including hilar cholangiocarcinoma and distal cholangiocarcinoma, and had undergone radical resection;
- The pathology report of the patient must confirm complete resection (recovery from the operation to be disease-free, and the sample has negative margins R0, R1);
- The patient must be treated within 12 weeks after the radical resection;
- No anti-tumor treatment before radical resection, including radiotherapy and chemotherapy, targeted therapy and immunotherapy;
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- ECOG score 0-1 points;
- Expected survival time> 6 months;
- With sufficient organ and bone marrow function, the laboratory test values within 7 days before randomization meet the following requirements (no blood components, cell growth factors, albumin and other corrective treatment drugs are allowed to meet the conditions), as follows :1) Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L; platelet count (platelet, PLT) ≥75×10 9/L; hemoglobin content (hemoglobin, HGB) ≥9.0 g /dL;2) Liver function: serum total bilirubin (TBIL) ≤ 2×upper limit of normal value (ULN); alanine aminotransferase (ALT) and aspartate amino transfer Enzyme (aspartate transferase, AST) ≤5×ULN; serum albumin ≥28 g/L; alkaline phosphatase (alkaline phosphatase, ALP) ≤5×ULN;3) Renal function: serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (clearance of creatinine, CCr) ≥ 50 mL/min (Cockcroft-Gault formula); urine routine results show urine protein <2+; against baseline For patients whose urine protein is ≥2+ by routine urine test, 24-hour urine collection and 24-hour urine protein quantitative <1g should be performed;4) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
- Female patients of childbearing age or male patients whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the last treatment.
Who cannot join
- Diagnosis of other malignant diseases outside the biliary tract within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically excised carcinoma in situ);
- Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration;
- Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
- Have received radiotherapy for biliary tract tumors in the past;
- Received Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) systemic systemic treatment within 2 weeks before the first administration;
- An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatments. Known history of primary immunodeficiency. Only patients with positive autoimmune antibodies need to confirm whether there are autoimmune diseases based on the judgment of the investigator;
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- Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks before the first administration of the study. Note: Physiological doses of glucocorticoids are allowed (≤10 mg/day prednisone or equivalent drugs);
- There is clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included in the group)
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- Those who are known to be allergic to the active ingredients or excipients of Sintilimab
- Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or hair loss)
- Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive)
- Untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of normal value of the laboratory department of the research center).Note: Hepatitis B subjects who meet the following criteria can also be included in the group:1) The HBV viral load before the first administration is less than 2.5×103 copies/ml (500 IU/ml), and the subject should receive anti-HBV treatment during the entire study treatment period;2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is no need to receive preventive anti-HBV treatment, but close monitoring of virus reactivation is required.
- Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection);
- Have received a live attenuated vaccine within 4 weeks before the first dose;
- Pregnant or lactating women;
- There are any serious or uncontrollable systemic diseases, such as:1) The resting electrocardiogram has major abnormalities in rhythm, conduction, or morphology that are severe and difficult to control, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;2) Unstable angina pectoris, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) grade ≥ 2;3) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, occurred within 6 months before being selected for treatment;4) Major surgery (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures have been received within 4 weeks before the first administration. Have received tissue biopsy or other minor surgical procedures within 7 days before the first administration, except for venipuncture catheters for the purpose of intravenous infusion;5) Unsatisfactory blood pressure control (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);6) Active tuberculosis;7) There is an active or uncontrolled infection that requires systemic treatment;8) There is clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;10) Poor control of diabetes (fasting blood glucose (FBG)> 10mmol/L);11) Urine routine test shows urine protein ≥++, and the 24-hour urine protein quantitative is confirmed to be >1.0 g;12) Patients with mental disorders who cannot cooperate with treatment;
- The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subject from participating in the study, or the investigator believes that it is not suitable for inclusion in the group. The investigator believes that there are other potential risks and is not suitable for participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University.
This is a single-center, single-arm, prospective phase II clinical study to evaluate the effectiveness and safety of Sintilimab combined with capecitabine in patients after radical resection of cholangiocarcinoma.
The primary endpoint of the study:
- 2-year recurrence-free survival rate
Secondary endpoint:
- Overall survival (OS), 1y RFS%, 2y OS%, 3y OS%, time to recurrence (TTR), RFS;Safety and tolerability.
Study drugs, dosages, and methods of administration:
- Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles.
- Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles.
- Conditions
- Cholangiocarcinoma
- Being tested
- Sintilimab
- Keywords
- PD-1 Inhibitor, Capecitabine, Adjuvant Treatment
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called Capecitabine
- Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles.
- Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles.
Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles. Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2y RFS%
2-year recurrence-free survival rate
Measured: up to 24 months
Secondary outcomes (6)
OS
overall survival
Measured: up to 36 months
1y RFS%
1-year recurrence-free survival rate
Measured: up to 12 months
2y OS%
2-year overall survival rate
Measured: up to 24 months
3y OS%
3-year overall survival rate
Measured: up to 36 months
TTR
time to recurrence
Measured: up to 36 months
RFS
recurrence-free survival
Measured: 1-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jinxue Zhou, MD, Study chair, Henan cancer hospital,affiliated cancer hospital of zhengzhou university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207735
- Sponsor's protocol ID
- 2021-246
- Acronym
- SCRCA
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University.
- ClinicalTrials.gov ID
- NCT05207735
- Acronym / sponsor ID
- SCRCA / 2021-246
- Conditions
- Cholangiocarcinoma
- Keywords
- PD-1 Inhibitor, Capecitabine, Adjuvant Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Jan 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 single-center, single-arm, prospective phase II clinical study to evaluate the effectiveness and safety of Sintilimab combined with capecitabine in patients after radical resection of cholangiocarcinoma.
The primary endpoint of the study:
- 2-year recurrence-free survival rate
Secondary endpoint:
- Overall survival (OS), 1y RFS%, 2y OS%, 3y OS%, time to recurrence (TTR), RFS;Safety and tolerability.
Study drugs, dosages, and methods of administration:
- Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles.
- Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Drug: SintilimabSintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles. Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be between 18-75 years old;
- Sign written informed consent, and be able to comply with the visits and related procedures stipulated in the plan;
- Histopathological diagnosis was extrahepatic cholangiocarcinoma, including hilar cholangiocarcinoma and distal cholangiocarcinoma, and had undergone radical resection;
- The pathology report of the patient must confirm complete resection (recovery from the operation to be disease-free, and the sample has negative margins R0, R1);
- The patient must be treated within 12 weeks after the radical resection;
Key exclusion criteria (18 listed)
- Diagnosis of other malignant diseases outside the biliary tract within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically excised carcinoma in situ);
- Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration;
- Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
- Have received radiotherapy for biliary tract tumors in the past;
- Received Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) systemic systemic treatment within 2 weeks before the first administration;
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 |
|---|---|---|
| SintilimabAlso: Capecitabine* Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles. * Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles. | Drug | GROUP 1 |
Primary outcome
2y RFS%
Time frame: up to 24 months
2-year recurrence-free survival rate
6 secondary outcomes
OS
Time frame: up to 36 months
1y RFS%
Time frame: up to 12 months
2y OS%
Time frame: up to 24 months
3y OS%
Time frame: up to 36 months
TTR
Time frame: up to 36 months
RFS
Time frame: 1-36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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.
Jinxue Zhou, MD study chair
Henan cancer hospital,affiliated cancer hospital of zhengzhou university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab in people with Cholangiocarcinoma, run by Henan Cancer Hospital.
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 18 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jinxue Zhou, MD (13837175001, zhoujx888@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2y RFS% (time frame: up to 24 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 26 Jan 2022.