PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

Eligibility criteria

Qualifiers

The patient must sign an informed consent form;

Age 18-75 years old, both male and female;

ECOG performance status score (PS score) 0 or 1 point;

Child-Pugh score A period;

Disqualifiers

Unresectable PHC patients or postoperative diagnosis of PHC recurrence and metastasis ;

Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;

Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;

Severe cardiopulmonary and renal dysfunction;

Trial design

Treatments tested in this trial

  • PD-1antibody plus GEMOX

Treatment groups

62 Participants
are divided into 1 treatment group