A Phase Ib/II Clinical Study of Camrelizumab and Apatinib Plus GP in the Treatment of Advanced Bi… (NCT05742750) | Clinical Trial Compass
CompletedPhase 1/2
A Phase Ib/II Clinical Study of Camrelizumab and Apatinib Plus GP in the Treatment of Advanced Biliary Tract Cancer
China49 participantsStarted 2023-04-27
Plain-language summary
The objective of this study is to investigate the safety and tolerability of camrelizumab combined with apatinib and chemotherapies (gemcitabine and cisplatin) in patients with advanced biliary tract cancer (BTC).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject must be able to comprehend and willing to sign an informed consent form (ICF).
. Subject must have a pathologically or cytologically confirmed carcinoma (except neuroendocrine) of the biliary tract (intra-hepatic, extra-hepatic (hilar, distal) or gallbladder) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed cholangiocarcinoma/hepatocellular carcinoma histology are excluded.
. Subject must be 18-75 years of age at the time of signature of the ICF.
. Subject must have an ECOG performance status of 0-1. Estimated life expectancy no less than 3 months.
. Subject may not have received prior systemic treatment (chemotherapy or targeted therapy) for advanced BTC. Prior peri-operative chemotherapy is permitted provided it was completed \> 6 months from enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined camrelizumab, apatinib, and gemcitabine plus cisplatin — that's four treatments at once — so how does the toxicity profile from this study compare to what I might experience on a more standard regimen for my biliary tract cancer?
2Since this was a Phase Ib/II study, it was partly designed to figure out the right dose of apatinib — does that mean the safety and benefit data is still considered early or preliminary, and how should that affect how much weight I put on its results?
3The trial has now completed recruitment, so are its findings published or available yet, and if so, what did the objective response rate actually show for patients with locally advanced or metastatic disease like mine?
4Given that this trial tested a specific combination that included an anti-VEGFR drug like apatinib alongside immunotherapy, is there a reason to consider this approach over the current standard first-line options for advanced biliary tract cancer, or would standard treatment be a better starting point for me?
5Are there other ongoing or completed trials building on this combination that might be relevant to my situation, or is this one of the more cutting-edge approaches my care team would consider for advanced biliary tract cancer right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject must have a lesion that can be accurately assessed at baseline by CT or magnetic resonance imaging (MRI) and is suitable for repeated assessment in accordance with RECIST v1.1.
. Subject must have normal organ and marrow function as defined below within 14 days of study entry:
. Any investigational agents or study drugs from a previous clinical study within 4 weeks of the first dose of study treatment.
. Malignancies other than BTC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or breast ductal carcinoma in situ treated surgically with curative intent).
. Prior history of brain metastasis (unless previously treated, asymptomatic and stable for at least 3 months) or organ transplant.
. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
. Active bleeding during the last 4 weeks prior to screening or in the investigator's judgment, the existence of high bleeding tendency lesions such as active gastrointestinal ulcers or prominent esophageal or gastric varices.
. Significant cardiovascular disease, including:
. Heart disease classified as New York Heart Association class III or IV.