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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Envafolimab plus Gemcitabine&Cisplatin

    Drug

    Envafolimab a programmed death ligand immune check inhibitor Per Investigator decision

  • Gemcitabine&Cisplatin

    Drug

    The standard of care for the patients with unresectable/metastatic biliary tract cancer

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: EnvafolimbExperimental treatment 1 intervention
Group B: Gemcitabine&CisplatinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

To evaluate the progression-free survival (PFS) of envafolimab in combination with gemcitabine plus cisplatin (GemCis) versus first-line treatment of GemCis in patients with advanced biliary tract cancers (BTC).

Time frame
Observed by 12 weeks

Secondary outcomes

1

Overall survival (OS)

To evaluate the overall survival (OS) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

Time frame
Observed by 12 weeks after progressive disease or end of treatment
2

Objective response rate(ORR)

To evaluate the objective response rate (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

Time frame
Observed by 12 weeks
3

Duration of response (DoR)

To evaluate the duration of response (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

Time frame
Observed by 12 weeks
4

Disease control rate (DCR)

To evaluate the disease control rate (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

Time frame
Observed by 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

3D Medicines (Sichuan) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: