Not Yet RecruitingPhase 2

Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers

126 participantsStarted 2027-06-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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);
✓. ECOG PS score 0 or 1 (see Appendix 1);
✓. Expected survival ≥ 12 weeks;
✓. Subjects with at least one measurable lesion (RECIST 1.1 criteria, see Appendix 2);
✓. Subject must have adequate major organ and bone marrow functions (no blood transfusion and no use of hematopoietic growth factor within 14 days before the first dose of study treatment):

Exclusion criteria

✕. 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;
✕. Has prior liver transplantation;
✕. Has known active brain metastases or spinal cord compression; subjects with previously treated brain metastases may be enrolled if their clinical condition is stable and radiographic evidence shows no disease progression within 4 weeks prior to the first dose of investigational product treatment, and corticosteroid therapy is not required within 4 weeks prior to the first dose of investigational product treatment;
✕. Has a known additional malignant tumor in the past 5 years (except for skin basal cell or squamous cell carcinoma, or cervical, breast and other carcinoma in situ after radical surgery);
✕. Has received major surgical procedures (except biopsy) or incomplete healing of surgical wound within 4 weeks prior to the first dose of investigational product treatment;

What they're measuring

Progression-free survival (PFS)

Timeframe: Observed by 12 weeks

Trial details

NCT IDNCT04910386

Sponsor3D Medicines (Sichuan) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06

View on ClinicalTrials.gov More Biliary Tract Neoplasms trials