Unresectable Intrahepatic CholangiocarcinomaPhase 2NCT05738057
Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and PD1 Antibody in Advanced and Unresectable Intrahepatic Cholangiocarcinoma
A Phase 2 study testing Camrelizumab, Gemcitabine Injection and Cisplatin injection in people with Unresectable Intrahepatic Cholangiocarcinoma, run by Hua Li at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Intrahepatic Cholangiocarcinoma
- What is being tested?
- Camrelizumab, Gemcitabine Injection and Cisplatin injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, male or female;
- Histopathologically confirmed intrahepatic cholangiocarcinoma;
- Tumor is unresectable assessed by the expert group (R0 resection CANNOT be achieved) and the life expectancy is more than 3 months;
- Presence of at least one measurable lesion assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Child-Pugh score ≤ 7;
- Adequate organ function (neutrophil count of ≥1.5×10^9 cells/L, hemoglobin concentrations of ≥90 g/L, platelet cell count of ≥100×10^9 cells/L, bilirubin ≤1.5×ULN, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5×ULN, serum creatinine ≤ 1.5 x ULN, Thyroid stimulating hormone (TSH) ≤ 1 x ULN;
- The patient must be required to sign an informed consent form;
Who cannot join
- Patients who have received previous treatment with interventional therapy, radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy (PD-1, PD-L1, CLTA-4 antibody, etc), or surgery within the last 2 months;
- Patients with other malignant tumors within the last 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active;
- Active infection requiring systemic therapy;
- Human immunodeficiency virus (HIV) positive;
- Have an active, known, or suspected autoimmune disease. Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled;
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- Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Abnormal blood coagulation (INR >1.5, or PT>ULN+4s, or APTT >1.5 x ULN), with a bleeding tendency or receiving thrombolytic or anticoagulant therapy;
- Pregnant or lactating women;
- Participated in other trials within the last 4 weeks;
- Has a history of allergy to platinum;
- Other factors that may influence the safety of the subject or the compliance of the test by the investigator. Serious illnesses (including mental illness), severe laboratory tests, or other family or social factors that require combined treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
About this study
Official title: Combined Therapy Using D-TACE, Gemcitabine and Cisplatin Chemotherapy, and PD1 Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Single-center, Single-arm Trial
The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:
- Whether combined therapy using D-TACE, Gem/Cis, and PD-1 works well to convert unresectable ICC to resectable.
- Whether combined therapy using D-TACE, Gem/Cis, and PD-1 is safe. Participants will receive D-TACE (CalliSpheres with Gem 30 mg), camrelizumab (200 mg) plus gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2), and 24 months follow-up.
- Being tested
- Camrelizumab, Gemcitabine Injection, Cisplatin injection, Cisplatin-Eluting Beads, D-TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
200mg on day1 of every 3 weeks, starting on day1 of cycle1
Gemcitabine InjectionDrug
1000mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
Cisplatin injectionDrug
25mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
Cisplatin-Eluting BeadsDrug
used for D-TACE
D-TACEProcedure or surgery
TACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary.
| Study group | Role | What they receive |
|---|---|---|
| Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab | Experimental | D-TACE with cisplatin-eluting beads. More TACE can be done if clinically necessary.
Camrelizumab (200 mg, Intravenous drips (ivd), D1/3W) plus Gem (1000 mg/m2, ivd, D1\&8/3W) and Cis (25 mg/m2, ivd, D1\&8/3W). Three weeks are one cycle of treatment. Chemotherapy lasted for no more than 12 cycles. Receives: Drug: Camrelizumab; Drug: Gemcitabine Injection; Drug: Cisplatin injection; Drug: Cisplatin-Eluting Beads; Procedure: D-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Rate of unresectable ICC convert to resectable in combination therapy
Measured: 12 months
Secondary outcomes (8)
Incidence of adverse events
Rate of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 months
Objective Response Rate (ORR)
ORR according to RECIST 1.1 using investigator assessment
Measured: 12 months
Deepness of response (DpR)
DpR according to RECIST 1.1 using investigator assessment
Measured: 12 months
Disease control rate (DCR)
DCR according to RECIST 1.1 using investigator assessment
Measured: 12 months
Rate of R0 resection
R0 resection is defined as no tumor remains at the cutting edge and no tumor cells remain at the cutting edge under the microscope
Measured: 12 months
Overall Survival (OS)
OS is defined as the time from date of combined theray start to the date of death from any cause or to the date of last follow-up if patients are alive.
Measured: 12 months
Progression-free Survival (PFS)
From the beginning date of combined therapy to the date of disease progression. PFS according to RECIST 1.1 using investigator assessment
Measured: 12 months
Recurrence-free Survival (RFS)
RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. RFS according to RECIST 1.1 using investigator assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 Jun 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Li, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yang Yang, MD&PhD, Study chair, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738057
- Sponsor's protocol ID
- [2023]02-116-01
- Status last verified
- Nov 2023
- First submitted
- 14 Feb 2023
- Last updated
- 29 Nov 2023
- Results posted
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Therapy Using D-TACE, Gemcitabine and Cisplatin Chemotherapy, and PD1 Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Single-center, Single-arm Trial
- ClinicalTrials.gov ID
- NCT05738057
- Acronym / sponsor ID
- [2023]02-116-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Hua LiUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Feb 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 clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:
- Whether combined therapy using D-TACE, Gem/Cis, and PD-1 works well to convert unresectable ICC to resectable.
- Whether combined therapy using D-TACE, Gem/Cis, and PD-1 is safe. Participants will receive D-TACE (CalliSpheres with Gem 30 mg), camrelizumab (200 mg) plus gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2), and 24 months 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 |
|---|---|---|
| Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab | Experimental | Drug: Camrelizumab, Drug: Gemcitabine Injection, Drug: Cisplatin injection, Drug: Cisplatin-Eluting Beads, Procedure: D-TACED-TACE with cisplatin-eluting beads. More TACE can be done if clinically necessary. Camrelizumab (200 mg, Intravenous drips (ivd), D1/3W) plus Gem (1000 mg/m2, ivd, D1\&8/3W) and Cis (25 mg/m2, ivd, D1\&8/3W). Three weeks are one cycle of treatment. Chemotherapy lasted for no more than 12 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old, male or female;
- Histopathologically confirmed intrahepatic cholangiocarcinoma;
- Tumor is unresectable assessed by the expert group (R0 resection CANNOT be achieved) and the life expectancy is more than 3 months;
- Presence of at least one measurable lesion assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (12 listed)
- Patients who have received previous treatment with interventional therapy, radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy (PD-1, PD-L1, CLTA-4 antibody, etc), or surgery within the last 2 months;
- Patients with other malignant tumors within the last 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active;
- Active infection requiring systemic therapy;
- Human immunodeficiency virus (HIV) positive;
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 |
|---|---|---|
| Camrelizumab200mg on day1 of every 3 weeks, starting on day1 of cycle1 | Drug | Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab |
| Gemcitabine Injection1000mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1 | Drug | Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab |
| Cisplatin injection25mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1 | Drug | Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab |
| Cisplatin-Eluting Beadsused for D-TACE | Drug | Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab |
| D-TACETACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary. | Procedure or surgery | Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab |
Primary outcome
Conversion rate
Time frame: 12 months
Rate of unresectable ICC convert to resectable in combination therapy
8 secondary outcomes
Incidence of adverse events
Time frame: 12 months
Objective Response Rate (ORR)
Time frame: 12 months
Deepness of response (DpR)
Time frame: 12 months
Disease control rate (DCR)
Time frame: 12 months
Rate of R0 resection
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Progression-free Survival (PFS)
Time frame: 12 months
Recurrence-free Survival (RFS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- 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.
Yang Yang, MD&PhD study chair
Third Affiliated Hospital, 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 Camrelizumab, Gemcitabine Injection and Cisplatin injection in people with Unresectable Intrahepatic Cholangiocarcinoma, run by Hua Li 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 12 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 29 Nov 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 Hua Li, MD&PhD (+8613060975202, lihua100@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: 12 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 29 Nov 2023.