Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients W… (NCT05451290) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer
China30 participantsStarted 2022-11-01
Plain-language summary
This is a phase II open-label, one-arm, multicenter study aimed to explore the efficacy and safety of perioperative (neoadjuvant and adjuvant) treatment for patients with advanced biliary tract carcinoma.
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
. Informed consent document must be signed.
. Aged 18-75 years old, both genders.
. Pathologically confirmed biliary tract adenocarcinoma and haven't been treated before.
. An Eastern Cooperative Oncology Group performance status of 0 to 1.
. Locally advanced biliary tract adenocarcinoma confirmed by MDT discussion.
. The function of vital organs meets the following requirements:
. At least 1 measurable lesion as defined by RECIST 1.1.
. Women of reproductive age need to take effective contraceptive measures during and within 3 months of the end of medication.
Exclusion criteria
. Subject has any active autoimmune disease or history of autoimmune disease will not be included, nor will patients with active tuberculosis or hepatitis or HIV.
. Subjects with illness or medical conditions that could jeopardize their sugery, such as severe cardiopulmonary insufficiency and coagulation disorders, cannot be enrolled.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
1-year EFS rate
Timeframe: 1 year
Trial details
NCT IDNCT05451290
SponsorFirst Affiliated Hospital of Zhejiang University
. Subjects with active malignancies other than BTC within 5 years should be excluded, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and superficial bladder cancer \[Ta, Tis \& T1\] and papillary thyroid cancer.
. Any unstable systemic disease which might need systemic treatment should not be enrolled (including active infection, liver or renal disease, metabolic disease, acute cerebral infarction or hemorrhage), or serious co-morbidities that by the judgment of the investigator, may compromise the patient's safety or impair the patient's ability to complete the study.
. Subjects who have significant cardiovascular events should not be enrolled, for example: congestive heart failure \> NYHA class 2, unstable angina, active coronary artery disease (CAD) (only allow the subjects with presence of myocardial infarction more than 1 year prior to study); severe arrhythmias in need of treatment (only allow those been treated with β-blockers or digoxin) or uncontrolled hypertension.
. Subjects with history of neurological or psychiatric disease, including epilepsy or dementia or diseases alike should not be enrolled.
. Subjects with interstitial lung disease or a history of interstitial pneumonia should not be enrolled.
. Subjects who had participated in other anti-tumor clinical trials within 4 weeks prior to enrollment should be avoided.