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 range18 Years – 75 Years
SexALL
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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.
✕. 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.
✕
What they're measuring
1
1-year EFS rate
Timeframe: 1 year
Trial details
NCT IDNCT05451290
SponsorFirst Affiliated Hospital of Zhejiang University
. 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.