Intrahepatic Cholangiocarcinoma
Conditions
Brief summary
This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with advanced intrahepatic cholangiocarcinoma (ICC).
Detailed description
It is estimated that 50 patients who met the study criteria will be enrolled in 3 years and treated with Camrelizumab plus Apatinib in SYSUCC. The investigators will follow up and collect subjects' data to evaluate the efficacy and safety of treatment, including objective response rate (ORR) and Progression-free Survival (PFS) and Overall Survival (OS), until disease progression or death. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.
Interventions
DRUGCamrelizumab
Camrelizumab (Jiangsu HengRui Medicine Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.
DRUGApatinib
Apatinib is a novel angiogenesis inhibitor vascular endothelial growth factor 2.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histopathologically confirmed advanced ICC, or combined hepatocellular and cholangiocarcinoma (cHCC-CC, composition of cholangiocarcinoma \>50%). nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies. * Have at least one measurable lesion (in accordance with RECIST v1.1); the measurable lesion has a long diameter ≥ 10 mm or lymphadenopathy has a short diameter ≥ 15 mm in spiral CT scan. * Child-Pugh Class: Grade A * ECOG-PS score 0 or 1 * Life Expectancy of at least 3 months * Have the required screening laboratory values
Exclusion criteria
* Extrahepatic cholangiocarcinoma (EHCC) and primary liver cancer. other active malignant tumors except for ICC within 3 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled. * Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[subjects that can be controlled with hormone replacement therapy only can be enrolled\]); subjects with skin diseases that does no need systemic treatment, for example, leukoderma, psoriasis, alopecia, those with controlled type I diabetes by insulin or those with asthma that has been completely resolved in childhood and with no need of any intervention can be enrolled; while subjects with asthma who need bronchodilator for medical intervention cannot be enrolled; * Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) and St. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signing informed consent form. * Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1), or previous use of Apatinib. * Known history of serious allergy to any monoclonal antibody or Apatinib. * Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption. * Previous or current presence of metastasis to central nervous system. * Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to the start of study treatment (for example, subjects who are given with preventive antibiotics for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study); * Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Three years | A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Three years | Duration from the date of initial treatment to the date of death due to any cause. |
| Disease Control Rate (DCR) | Two years | Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit. |
| Objective Response Rate (ORR) | Three years | Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients. |
| Time to Progression (TTP) | Two years | A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) |
| Adverse events (AE) | Two years | Any adverse events related with treatment drugs and details include adverse events type, frequency and severity. |
| Duration of Response (DoR) | Two years | Duration from the first time reported partial response or complete response to the first time of disease progression or death. |
Countries
China
Contacts
Primary ContactLi Xu, MD., PhD.
Backup ContactZhishan Lin
Outcome results
None listed