Combining Camrelizumab and Apatinib for Advanced Intrahepatic Cholangiocarcinoma
A Single-arm Phase II Study to Evaluate Camrelizumab in Combination With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
This study is testing if a combination of two medications, Camrelizumab and Apatinib, can help people with advanced intrahepatic cholangiocarcinoma who can't have surgery feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Apatinib, immunotherapy, Camrelizumab |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT04454905 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Camrelizumab in combination with Apatinib for patients with advanced intrahepatic cholangiocarcinoma (ICC). It is a single-arm, open-label, non-randomized study that aims to enroll 50 patients over three years at Sun Yat-sen University Cancer Center. Participants will be monitored for treatment response, including objective response rate, progression-free survival, and overall survival, with additional analysis of potential biomarkers through histopathology and multi-omics data. The study focuses on patients who are not eligible for curative treatments.
Who should consider this trial
Good fit: Ideal candidates include those with histopathologically confirmed advanced ICC who are not eligible for curative resection or other ablative therapies.
Not a fit: Patients with extrahepatic cholangiocarcinoma or other active malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced ICC.
How similar studies have performed: While this approach is being explored, similar combinations have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Li Xu — Guangzhou, Guangdong, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Minshan Chen, MD., PhD. — Sun Yat-sen University
- Study coordinator: Li Xu, MD., PhD.
- Email: xuli@sysucc.org.cn
- Phone: +862087343582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.