Cholangiocarcinoma Non-resectablePhase 2NCT05978609
Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer
A Phase 2 study testing Candonilimab, Cisplatin and Gemcitabine in people with Cholangiocarcinoma Non-resectable, run by West China Hospital at 1 site in China.
Trial summary
The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma Non-resectable
- What is being tested?
- Candonilimab, Cisplatin and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Jul 2026
- 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
- Obtain written informed consent before implementing any experimental procedures.
- Age between 18 and 75 years (any gender).
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma).
- No prior systemic treatment, curative surgery, or adjuvant therapy allowed within the past 6 months.
- Expected survival time > 3 months.
- Presence of at least one measurable lesion according to RECIST 1.1 criteria.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.
- Adequate organ function, with the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥ 1.5x10^9/L, without the use of granulocyte-colony stimulating factor in the past 14 days.
- Platelet count ≥ 90x10^9/L, without transfusion in the past 14 days.
- Hemoglobin > 9 g/dL, without transfusion or use of erythropoietin-stimulating agents in the past 14 days.
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN for patients with liver metastases).
- Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 ml/min.
- Coagulation function within normal limits, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free T3) and free thyroxine (FT4) within the normal range can still be included.
- Normal cardiac enzymes (clinically insignificant isolated laboratory abnormalities are allowed, as determined by the investigator).
- For premenopausal female subjects, a negative pregnancy test result (urine or serum) should be obtained within 3 days before the first dose of study drug (Day 1 of Cycle 1). If urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Postmenopausal female is defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
- If there is a risk of pregnancy, all subjects (both male and female) must use contraception with a failure rate of less than 1% per year throughout the entire treatment period and for 120 days after the last dose of study drug.
Who cannot join
- Diagnosis of malignant diseases other than extrahepatic bile duct cancer, excluding completely resected basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma within the past 5 years.
- Tumors located in the ampulla of Vater.
- Currently participating in an interventional clinical study or received other investigational drugs or investigational device treatment within 4 weeks prior to the first dose of study drug.
- Previously received therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another T-cell receptor with inhibitory or co-stimulatory function (e.g., CTLA-4, OX-40, CD137).
- Previously received palliative radiotherapy for biliary tumors, excluding postoperative adjuvant radiotherapy.
- Received traditional Chinese medicine or immune modulatory drugs with anti-tumor indications within 2 weeks prior to the first dose of study drug (including thymosin, interferon, interleukins), except for local use to control pleural effusion.
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- Active autoimmune diseases requiring systemic treatment within 2 years prior to the first dose of study drug, or known history of primary immunodeficiency diseases. Patients with positive autoimmune antibodies alone will be evaluated by the investigator to determine if they have autoimmune diseases.
- Currently receiving systemic corticosteroid therapy (excluding intranasal, inhaled, or topical corticosteroids) or any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug. Physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent) are permitted.
- Uncontrolled pleural effusion or ascites that requires drainage or has not shown a significant increase in the past 3 days in patients who do not require drainage or whose drainage has been stopped.
- Prior solid organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to the study drug, Candonilimab active substance, or excipients.
- Insufficient recovery from any toxicities and/or complications related to previous interventions before starting treatment (i.e., ≤ Grade 1 or returning to baseline, excluding fatigue or alopecia).
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies).
- Untreated active hepatitis B defined as positive HBsAg and detectable HBV-DNA levels above the upper limit of normal at the study center. Note: The following HBV-infected patients may be included:
- HBV viral load <2.5 × 10^3 copies/mL (500 IU/mL) prior to the first dose of study drug, and patients should receive anti-HBV therapy throughout the study treatment.
- For patients who are anti-HBc positive, HBsAg negative, anti-HBs negative, and HBV DNA negative, no prophylactic anti-HBV therapy is required, but viral reactivation needs to be closely monitored.
- Active hepatitis C infection (positive for hepatitis C virus (HCV) antibodies and HCV-RNA levels above the lower limit of detection).
- Vaccination with live attenuated vaccines within 4 weeks prior to the first dose of study drug.
- Pregnant or lactating women.
- Presence of any severe or uncontrolled systemic diseases, including:
- Resting electrocardiogram with significant and symptomatic abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, grade II or higher cardiac conduction block, ventricular arrhythmia, or atrial fibrillation.
- Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ Grade 2.
- Any arterial thrombosis, embolism, or ischemia event within the past 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study drug or unhealed wounds, ulcers, or fractures. Minor surgical procedures, including venous puncture for intravenous infusion, within 7 days prior to the first dose of study drug are excluded.
- Poor blood pressure control (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
- Active pulmonary tuberculosis. Active or uncontrolled infections requiring systemic treatment. Clinical active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L). Urine analysis showing urinary protein ≥++ and confirmed 24-hour urinary protein >1.0 g.
- Presence of psychiatric disorders that would hinder compliance with treatment.
- Any medical history, evidence of disease, or abnormal laboratory values that could interfere with the study results, hinder the subject's full participation in the study, or pose other potential risks as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Tao Wang, Dr.
About this study
Official title: Efficacy and Safety of Cadonilimab Combined With Gemcitabine and Cisplatin in the First-line Treatment of Unresectable Locally Advanced or Metastatic Biliary Malignancies
The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are:
- Is this combined treatment protocol safe for these patients?
- Is this combined treatment protocol effective in treating these patients?
Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
- Conditions
- Cholangiocarcinoma Non-resectable
- Being tested
- Candonilimab, Cisplatin, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandonilimabDrug
Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
CisplatinDrug
Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
GemcitabineDrug
gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
| Study group | Role | What they receive |
|---|---|---|
| Candonilimab in combination with cisplatin and gemcitabine | Experimental | This study is a single-arm study to evaluate the safety and efficacy of candonilimab combined with cisplatin and gemcitabine in advanced biliary tract tumors
Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； Receives: Drug: Candonilimab; Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
Defined as the proportion of the subjects who have a complete response (CR) and partial response (PR) per RECIST 1.1 in enrolled subjects
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by West China 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wentao Wang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978609
- Sponsor's protocol ID
- 2023-1036
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cadonilimab Combined With Gemcitabine and Cisplatin in the First-line Treatment of Unresectable Locally Advanced or Metastatic Biliary Malignancies
- ClinicalTrials.gov ID
- NCT05978609
- Acronym / sponsor ID
- 2023-1036
- Conditions
- Cholangiocarcinoma Non-resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 7 Aug 2023 (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.
The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are:
- Is this combined treatment protocol safe for these patients?
- Is this combined treatment protocol effective in treating these patients?
Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candonilimab in combination with cisplatin and gemcitabine | Experimental | Drug: Candonilimab, Drug: Cisplatin, Drug: GemcitabineThis study is a single-arm study to evaluate the safety and efficacy of candonilimab combined with cisplatin and gemcitabine in advanced biliary tract tumors Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Obtain written informed consent before implementing any experimental procedures.
- Age between 18 and 75 years (any gender).
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma).
- No prior systemic treatment, curative surgery, or adjuvant therapy allowed within the past 6 months.
- Expected survival time > 3 months.
Key exclusion criteria (30 listed)
- Diagnosis of malignant diseases other than extrahepatic bile duct cancer, excluding completely resected basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma within the past 5 years.
- Tumors located in the ampulla of Vater.
- Currently participating in an interventional clinical study or received other investigational drugs or investigational device treatment within 4 weeks prior to the first dose of study drug.
- Previously received therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another T-cell receptor with inhibitory or co-stimulatory function (e.g., CTLA-4, OX-40, CD137).
- Previously received palliative radiotherapy for biliary tumors, excluding postoperative adjuvant radiotherapy.
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 |
|---|---|---|
| CandonilimabCandonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； | Drug | Candonilimab in combination with cisplatin and gemcitabine |
| CisplatinCisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； | Drug | Candonilimab in combination with cisplatin and gemcitabine |
| Gemcitabinegemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously； | Drug | Candonilimab in combination with cisplatin and gemcitabine |
Primary outcome
Objective response rate(ORR)
Time frame: through study completion, an average of 1 year
Defined as the proportion of the subjects who have a complete response (CR) and partial response (PR) per RECIST 1.1 in enrolled subjects
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Undecided
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A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
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Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
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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.
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 Candonilimab, Cisplatin and Gemcitabine in people with Cholangiocarcinoma Non-resectable, run by West China 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 19 inclusion and 30 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 7 Aug 2023. 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?
Contact Tao Wang (17844623533, wangshoutao1219@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: through study completion, an average of 1 year). 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 Aug 2023.