Status:
UNKNOWN
Camrelizumab in Combination With Apatinib in Advanced ICC: A Single-arm Phase II Study
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 wit...
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' da...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04454905
Start Date
August 1 2020
End Date
July 1 2025
Last Update
April 19 2023
Active Locations (2)
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1
Li Xu
Guangzhou, Guangdong, China, 510060
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060