Trial Title:
First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC
NCT ID:
NCT06370663
Condition:
Intrahepatic Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Conditions: Keywords:
Intrahepatic Cholangiocarcinoma
Radiotherapy
Hepatic Arterial Infusion Chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Combining radiotherapy with Hepatic Arterial Infusion Chemotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Radiotherapy + Hepatic Arterial Infusion Chemotherapy (Gesitabine) + Chemotherapy (GEMOX)
Arm group label:
Radiotherapy plus HAIC
Other name:
Hepatic Arterial Infusion Chemotherapy (GEMOX)
Other name:
Chemotherapy (Gesitabine)
Intervention type:
Drug
Intervention name:
HAIC (GEMOX)
Description:
Hepatic Arterial Infusion Chemotherapy (GEMOX)
Arm group label:
Radiotherapy plus HAIC
Other name:
HAIC
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Chemotherapy (Gesitabine)
Arm group label:
Radiotherapy plus HAIC
Other name:
Chemotherapy (Gesitabine)
Summary:
The median survival of intrahepatic cholangiocarcinoma remains less than one year,
highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC),
especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due
to increased local drug concentration and reduced systemic toxicity. A combined approach
of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for
locally advanced cholangiocarcinoma. However, clinical research on this combination is
lacking as first-line therapy for unresectable ICC. Therefore, a single-center,
single-arm study aims to assess this treatment approach's safety, efficacy, and molecular
predictors. Improved HAIC delivery through modified percutaneous implantation provides a
reliable pathway for effective treatment. In conclusion, exploring the synergistic
effects of radiotherapy and HAIC in ICC could pave the way for more effective and
personalized treatment strategies for this challenging cancer type.
Detailed description:
Intrahepatic cholangiocarcinoma (ICC) ranks as the second most common primary liver
cancer, constituting 15%-20% of malignant liver tumors, with a rising incidence trend.
Unlike hepatocellular carcinoma (HCC), ICC displays higher invasiveness and metastatic
potential. Surgical resection remains the optimal treatment, yet many patients present
with unresectable disease or metastasis, limiting surgical options. Chemotherapy,
particularly the GC regimen, is standard for unresectable and metastatic ICC. Studies
like ABC-02 have improved survival with GC chemotherapy compared to gemcitabine
monotherapy. However, the median survival remains less than one year, highlighting the
need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with
fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased
local drug concentration and reduced systemic toxicity. A combined approach of
radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally
advanced cholangiocarcinoma. However, clinical research on this combination is lacking as
first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study
aims to assess this treatment approach's safety, efficacy, and molecular predictors.
Improved HAIC delivery through modified percutaneous implantation provides a reliable
pathway for effective treatment. In conclusion, exploring the synergistic effects of
radiotherapy and HAIC in ICC could pave the way for more effective and personalized
treatment strategies for this challenging cancer type.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-75 years, both male and female.
- Histologically or cytologically confirmed primary cholangiocarcinoma (including
intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and gallbladder
carcinoma) or imaging-confirmed localized cholangiocarcinoma, staged as T1-4N0/N+M0
(according to AJCC 7th edition clinical staging).
- Ineligible for surgical treatment or refusal of surgical treatment upon
pre-treatment assessment.
- Presence of measurable lesions as per RECIST v1.1 criteria for evaluation.
- ECOG performance status: 0-1.
- Expected survival of more than 6 months.
- Tolerable function of major organs for treatment.
- Non-surgically sterilized or premenopausal female patients need to use a medically
accepted contraceptive method during the study treatment period and within 3 months
after the end of the study treatment.
Exclusion Criteria:
- Subjects with any active autoimmune disease or a history of autoimmune disease are
excluded.
- Patients with poorly controlled clinical symptoms or diseases related to the heart,
such as:
1. NYHA Class 2 or above heart failure
2. Unstable angina
3. Myocardial infarction within the past year
4. Clinically significant ventricular or supraventricular arrhythmias requiring
treatment or intervention
5. QTc >450 ms (males); QTc >470 ms (females)
- Abnormal coagulation function (INR >1.5 or PT >16s), bleeding tendencies, or
receiving thrombolytic or anticoagulant therapy.
- Subjects who have received radiation therapy, chemotherapy, steroid therapy,
surgery, or molecular targeted therapy within less than 4 weeks (or 5 half-lives of
the drug, whichever is longer) before the study drug's first dose, or who have not
recovered from adverse events caused by previous treatment (excluding alopecia) to
≤Grade 1 according to CTCAE.
- Subjects with clinically symptomatic ascites, pleural effusion, or pericardial
effusion requiring therapeutic puncture or drainage. Those who have had stable
ascites or effusion after drainage of pleural or pericardial effusion for at least 2
weeks before the first dose of the study drug can be included in the study.
- Subjects with significant hemoptysis in the last 2 months or hemoptysis of half a
teaspoon (2.5 ml) or more.
- Known hereditary or acquired bleeding and thrombotic tendencies (such as
hemophiliacs, coagulation disorders, thrombocytopenia, splenomegaly, etc.) or those
who have had arterial or venous thrombotic events within the last 6 months (prior to
first SHR-1210 administration).
- Subjects with active infections or unexplained fever >38.5°C during screening or
before the first dose of the study drug.
- Patients with objective evidence of pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe lung function
impairment, etc., either historically or currently.
- Subjects with congenital or acquired immunodeficiency (such as HIV infection) or
active hepatitis (HBV reference: HBV DNA test value exceeds the upper limit of
normal; HCV reference: HCV virus titer or RNA test value exceeds the upper limit of
normal).
- Use of other investigational drugs within 4 weeks prior to the first dose of the
study drug.
- Subjects with a history of or concurrent other malignancies (excluding cured basal
cell carcinoma and cervical carcinoma in situ).
- Subjects who may receive other systemic anti-tumor therapies during the study.
- Subjects who have previously received PD-1 antibody therapy or immune therapy
targeting PD-1/PD-L1.
- Vaccination with live vaccines within less than 4 weeks before the study drug's
administration or potentially during the study period.
- Other factors judged by the investigator that may necessitate premature termination
of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinbo Yue
Address:
City:
Jinan
Zip:
250000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Bo Yue, Doctor
Phone:
0531-67626929
Email:
Len.Xu@hotmail.com
Start date:
April 1, 2024
Completion date:
April 1, 2026
Lead sponsor:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06370663
