Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers
ConditionBiliary Tract Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor3D Medicines (Sichuan) Co., Ltd.
About this trial
This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers
Eligibility criteria
Qualifiers
Be ≥ 18 years of age;
Subjects must have a histopathological or cytological diagnosis of locally advanced or metastatic gallbladder cancer (GBC) or cholangiocarcinoma (CCA);
Subjects who have not received prior systemic therapy for advanced disease or who have received adjuvant or neoadjuvant chemotherapy in one regimen and relapsed > 6 months after the end of chemotherapy can be enrolled;
Child-Pugh liver function rating: class A (5-6 points) and better class B (7 points) (see Appendix 3);
Disqualifiers
Has participated in another clinical trials of other investigational drugs or investigational devices within 4 weeks prior to the first dose of investigational product treatment (palliative radiotherapy for bone metastases completed at least 2 weeks prior to investigational product treatment is allowed);
The investigator assesses liver metastases as 50% or more of the total liver volume;
Has ascites requiring drainage or treatment with diuretics, or pleural or pericardial effusion requiring drainage and/or associated with symptoms of tachypnea within 4 weeks prior to the first dose of investigational product treatment;
Has biliary obstruction with clinical intervention that has not resolved or requires anti-infective therapy as judged by the investigator 14 days prior to the first dose of investigational product treatment;
Trial design
Treatments tested in this trial
- Envafolimab plus Gemcitabine&Cisplatin
- Gemcitabine&Cisplatin
Treatment groups
126 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov