CholangiocarcinomaNCT05580328
An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma
A study testing Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic Therapy in people with Cholangiocarcinoma, run by Second Affiliated Hospital of Guangzhou Medical University.
Trial summary
After enrollment, they received photodynamic therapy and sonodynamic therapy for a maximum of 2 times, and the longest treatment time was 6 months.The investigator will judge whether the second photodynamic therapy+ sonodynamic therapy treatment treatment is necessary according to the tolerance and tumor progress of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Oct 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18, male or female
- Patients with advanced cholangiocarcinoma confirmed by imaging, biopsy or cytology (including hilar cholangiocarcinoma, middle and lower segment cholangiocarcinoma, ampullary tumor, etc.) who do not have the conditions for surgical resection due to vascular invasion and metastasis
- Karnofsky score ≥ 70
- The patient voluntarily participated in the trial and signed the informed consent form
Who cannot join
- The expected life span is less than 3 months
- White blood cells of subjects < 3.0 × 109/L, or hemoglobin is less than 80 g/L, or neutrophil is less than 1.5 × 109/L, or platelet<75 × 109/L, or other blood system diseases
- Blood creatinine > 1.5 times the upper limit of normal value
- In patients with severe liver function damage, ALT and/or AST>5 times the upper limit of normal value
- Have porphyria or allergy to porphyrin drugs
- Patients with active and untreated infection and/or acute bacterial or fungal infection (except biliary tract infection and cholecystitis) at the time of enrollment
Show all 11Show fewer
- Severe hypertension (180mmhg / 110mmhg) that has not been controlled after intervention treatment, or serious complications of hypertension, or serious complications of diabetes
- Have serious heart, lung and central nervous system diseases
- Patients with mental illness or mental retardation who cannot correctly describe their feelings or cannot take medicine as instructed by the doctor
- Female patients who have become pregnant or may become pregnant and are unwilling to take reasonable and effective contraceptive measures, or are breastfeeding, or patients and/or sexual partners hope to become pregnant during the study period
- In addition to the above, the investigator determined that the patients were not suitable for this study.
About this study
Official title: An Exploratory Clinical Study of Photodynamic Therapy With Hematoporphyrin Injection Combined With Sonodynamic Therapy in the Treatment of Inoperable Cholangiocarcinoma
After enrollment, they received photodynamic therapy and sonodynamic therapy for a maximum of 2 times, and the longest treatment time was 6 months.The investigator will judge whether the second photodynamic therapy+ sonodynamic therapy treatment treatment is necessary according to the tolerance and tumor progress of the subject. The second photodynamic therapy+ sonodynamic therapy treatmentwill be carried out at the end of the sixth month. After the treatment period, the patients will be followed up once in the first, third and sixth months respectively, and then every three months. The observation and follow-up were carried out from the first subject after randomization to the end of 24 months after the last case.
The inspection and follow-up evaluation on the 7th day of the treatment period, including vital sign examination, blood routine examination, urine routine examination, blood biochemical examination, electrocardiogram examination, recording the number of times of plastic stent/metal stent drainage/drainage tube replacement, evaluation of physical status scale, evaluation of quality-of-life scale, recording concomitant medication and adverse events.
Read more
At the end of the first, third and sixth month, you need to come to the hospital for follow-up evaluation. In the test group, the investigator shall judge whether the second photodynamic therapy is needed at the end of the sixth month according to the tolerance and tumor progression of the subject. Before receiving the next photodynamic therapy, your body and quality of life must be evaluated according to KPS score and quality of life scale Arrange laboratory and relevant examinations. If the second photodynamic therapy is needed, continue to record the concomitant medication and adverse events at this stage.
During the follow-up period, after the longest treatment period of 6 months, a follow-up was conducted every 3 months until the end of 24 months after the last subject was enrolled in the scheme. Your survival, replacement of plastic stent/metal stent/drainage tube, biliary drainage, treatment methods for cholangiocarcinoma and serious adverse events were recorded during the follow-up.
- Conditions
- Cholangiocarcinoma
- Being tested
- Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic Therapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic TherapyDrug
Hematoporphyrin in tumor tissue will be greatly enhanced by the combination of Sonodynamic Therapy and Photodynamic Therapy and achieve better treatment effect.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Hematoporphyrin injection is a new drug for tumor photodynamic therapy approved by the State Food and Drug Administration of China. It is a representative drug of domestic photosensitizer with independent intellectual property rights developed and produced by Chongqing Huading Modern Biological Pharmaceutical Co., Ltd.
In the third phase clinical trial, the dosage of hematoporphyrin injection (5mg/kg) should be given intravenously 48-72 hours before laser irradiation for diagnosis and treatment, and skin test should be conducted before injection. Diagnostic laser wavelength is 514.5nm, power density is 10mW/cm2, therapeutic laser wavelength is 630-690nm, average output power density is 400mW/cm, and optical dose density is 200-400J/cm2 The chemical structure formula of hematoporphyrin is: C34H38N4O6, molecular weight: 598.70 Receives: Drug: Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of tumor evaluated by CT
Vealued by the size of tumor which was measured by CT
Measured: CT will be performed at the 24th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 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 Second Affiliated Hospital of Guangzhou Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Jiang, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580328
- Sponsor's protocol ID
- 2022-LCYJ-YY-09
- Status last verified
- Nov 2022
- First submitted
- 29 Sep 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Photodynamic Therapy With Hematoporphyrin Injection Combined With Sonodynamic Therapy in the Treatment of Inoperable Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05580328
- Acronym / sponsor ID
- 2022-LCYJ-YY-09
- Conditions
- Cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 14 Oct 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.
After enrollment, they received photodynamic therapy and sonodynamic therapy for a maximum of 2 times, and the longest treatment time was 6 months.The investigator will judge whether the second photodynamic therapy+ sonodynamic therapy treatment treatment is necessary according to the tolerance and tumor progress of the subject. The second photodynamic therapy+ sonodynamic therapy treatmentwill be carried out at the end of the sixth month. After the treatment period, the patients will be followed up once in the first, third and sixth months respectively, and then every three months. The observation and follow-up were carried out from the first subject after randomization to the end of 24 months after the last case.
The inspection and follow-up evaluation on the 7th day of the treatment period, including vital sign examination, blood routine examination, urine routine examination, blood biochemical examination, electrocardiogram examination, recording the number of times of plastic stent/metal stent drainage/drainage tube replacement, evaluation of physical status scale, evaluation of quality-of-life scale, recording concomitant medication and adverse events.
At the end of the first, third and sixth month, you need to come to the hospital for follow-up evaluation. In the test group, the investigator shall judge whether the second photodynamic therapy is needed at the end of the sixth month according to the tolerance and tumor progression of the subject. Before receiving the next photodynamic therapy, your body and quality of life must be evaluated according to KPS score and quality of life scale Arrange laboratory and relevant examinations. If the second photodynamic therapy is needed, continue to record the concomitant medication and adverse events at this stage.
During the follow-up period, after the longest treatment period of 6 months, a follow-up was conducted every 3 months until the end of 24 months after the last subject was enrolled in the scheme. Your survival, replacement of plastic stent/metal stent/drainage tube, biliary drainage, treatment methods for cholangiocarcinoma and serious adverse events were recorded during the follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic TherapyHematoporphyrin injection is a new drug for tumor photodynamic therapy approved by the State Food and Drug Administration of China. It is a representative drug of domestic photosensitizer with independent intellectual property rights developed and produced by Chongqing Huading Modern Biological Pharmaceutical Co., Ltd. In the third phase clinical trial, the dosage of hematoporphyrin injection (5mg/kg) should be given intravenously 48-72 hours before laser irradiation for diagnosis and treatment, and skin test should be conducted before injection. Diagnostic laser wavelength is 514.5nm, power density is 10mW/cm2, therapeutic laser wavelength is 630-690nm, average output power density is 400mW/cm, and optical dose density is 200-400J/cm2 The chemical structure formula of hematoporphyrin is: C34H38N4O6, molecular weight: 598.70 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18, male or female
- Patients with advanced cholangiocarcinoma confirmed by imaging, biopsy or cytology (including hilar cholangiocarcinoma, middle and lower segment cholangiocarcinoma, ampullary tumor, etc.) who do not have the conditions for surgical resection due to vascular invasion and metastasis
- Karnofsky score ≥ 70
- The patient voluntarily participated in the trial and signed the informed consent form
Key exclusion criteria (11 listed)
- The expected life span is less than 3 months
- White blood cells of subjects < 3.0 × 109/L, or hemoglobin is less than 80 g/L, or neutrophil is less than 1.5 × 109/L, or platelet<75 × 109/L, or other blood system diseases
- Blood creatinine > 1.5 times the upper limit of normal value
- In patients with severe liver function damage, ALT and/or AST>5 times the upper limit of normal value
- Have porphyria or allergy to porphyrin drugs
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 |
|---|---|---|
| Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic TherapyHematoporphyrin in tumor tissue will be greatly enhanced by the combination of Sonodynamic Therapy and Photodynamic Therapy and achieve better treatment effect. | Drug | treatment group |
Primary outcome
Size of tumor evaluated by CT
Time frame: CT will be performed at the 24th months.
Vealued by the size of tumor which was measured by CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Related trials for Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
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.
Questions about this trial
What is this clinical trial studying?
A study testing Hematoporphyrin Injection actived by photodynamic therapy combined with Sonodynamic Therapy in people with Cholangiocarcinoma, run by Second Affiliated Hospital of Guangzhou Medical University.
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 4 inclusion and 11 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 14 Nov 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.
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?
Size of tumor evaluated by CT (time frame: CT will be performed at the 24th 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 14 Nov 2022.