Gallbladder CancerPhase 2NCT06013943
Envafolimab Combined With GEMOX in First-line Treatment of Advanced GBC
A Phase 2 study testing Envafolimab+Gemox in people with Gallbladder Cancer, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The TOPAZ-1 study compared the advantages and disadvantages of immune checkpoint inhibitor anti-PD-L1 antibody combined with Gem/Cis chemotherapy (Gemcitabine and Cisplatin) and Gem/Cis chemotherapy alone in first-line treatment of advanced biliary tract tumors (BTC, which including gallbladder cancer). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Cancer
- What is being tested?
- Envafolimab+Gemox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite diagnosis of gallbladder carcinoma by histology or cytology；
- There is at least one measurable lesion (according to RECIST1.1);
- From 18 to 75 years old, ECOG physical strength score of 0-2;
- Basically normal bone marrow function: neutrophils >1.5x10^9/L, platelets >100x10^9/L;
- Adequate renal function: creatinine clearance > 60ml/min;
- Adequate liver function: bilirubin ≤1.5ULN;
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- No cardiac insufficiency or chest pain (medically uncontrollable); No myocardial infarction in the 12 months prior to study initiation;
- Estimated survival time ≥3 months;
- The patient must sign an informed consent form.
Who cannot join
- Previous systematic therapy, including chemotherapy, immunotherapy and targeted therapy;
- Secondary malignancies or other neoplasms (except superficial skin cancer and localized low-grade malignancies) occurring in the 3 years prior to study initiation;
- The presence of brain or meningeal metastasis;
- Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc. );
- Have received allogeneic organ transplantation (eg kidney transplantation, liver transplantation, heart transplantation, etc. );
- Patients who need long-term oral hormone therapy due to their underlying diseases;
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- Patients with interstitial pneumonia and autoimmune hepatitis;
- Inflammatory infections during the active period of infection or other patients who may have disabilities receive planned treatment;
- Persons with a history of uncontrolled substance abuse or mental disorders;
- Patients with concomitant diseases that, in the judgment of the investigator, may seriously endanger their own safety or may interfere with the completion of the study;
- Patients with poor renal function;
- Untreated complete/incomplete ileus that prevents eating or interferes with systemic administration;
- Participated in other clinical trials;
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Zhengang Yuan, Ph.D, +86-021-81887453, yuanzg@163.com
About this study
Official title: Envafolimab Combined With GEMOX in First-line Treatment of Advanced Gallbladder Cancer : A Single Center, Single Arm, Phase II Trial
The TOPAZ-1 study compared the advantages and disadvantages of immune checkpoint inhibitor anti-PD-L1 antibody combined with Gem/Cis chemotherapy (Gemcitabine and Cisplatin) and Gem/Cis chemotherapy alone in first-line treatment of advanced biliary tract tumors (BTC, which including gallbladder cancer). It was observed that chemotherapy combined with PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS).
As a standard first-line chemotherapy regimen for BTC too, Gemox chemotherapy (gemcitabine and cisplatin) has a median OS of 9.5 months, and non-inferior survival time to Gem/Cis chemotherapy. In addition, Gemox chemotherapy has been widely used in clinical practice because it reduces the requirement on patients' renal function and has good tolerance. Envafolimab is a novel fusion of humanized mono-domain PD-L1 antibody and human IgG Fc fragment, which has shown good efficacy and safety in a variety of solid tumors. It is safe and convenient to administer by subcutaneous injection. However, there is currently no clinical data on Envafolimab combined with GEMOX chemotherapy in patients with advanced gallbladder cancer (GBC).
The goal of this clinical trial is to evaluate its efficacy and related safety in patients with GBC. Eligible participants will receive Envafolimab (up to 12 months) plus gemcitabine and cisplatin (up to 6-8 cycles) until progression of radiological disease, unacceptable toxicity, or withdrawal from the study, whichever comes first.The primary endpoint was the 6-month PFS rate.
- Conditions
- Gallbladder Cancer
- Being tested
- Envafolimab+Gemox
- Keywords
- Envafolimab(immune checkpoint inhibitor anti-PD-L1 antibody)
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab+GemoxDrug
All of drugs were used for 6-8 cycles at the combined treatment stage, then Envafolimab and Gemcitabine continued at maintenance treatment stage until disease progression as defined by RECIST1.1, unacceptable toxicity, withdrawal from the study or death, or no more than 1 years.
Combined treatment stage: Envafolimab(150mg, iH, Q1W, Day1)+Gemcitabine(1000mg/m2, iv, Q3W, Day1 and Day8)+Cisplatin(1000mg/m2, iv, Q3W, Day1 and Day8);
Caintenance treatment stage: Envafolimab(400mg, iH, Day1, Q3W)+Gemcitabine(1000mg/m2, po, Day1-14, Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab+Gemox | Experimental | Not described Receives: Drug: Envafolimab+Gemox |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival rate (PFS)
Defined as the rate of patients had no disease progression or death (whichever occurred first) from the start of treatment to 6 months after treatment.
Measured: 6 months
Secondary outcomes (4)
Progression free survival (PFS)
Defined as the time from the start of treatment to the date of progressive disease, or death, whichever occurred first.
Measured: Up to two years
Overall survival (OS)
Defined as the time from the start of treatment to the date of death from any cause.
Measured: Up to two years
Disease control rate (DCR) per RECIST 1.1
Defined as patients achieving a complete response [CR] or partial response [PR] or stable disease [SD].
Measured: Once every 3 weeks (±7 days) from the first day of Envafolimab treatment for a maximum of 2 years until confirmed objective disease progression, death, and study termination.
Objective response rate (ORR) per RECIST 1.1
Defined as patients achieving a complete response [CR] or partial response [PR].
Measured: Once every 3 weeks (±7 days) from the first day of Envafolimab treatment for a maximum of 2 years until confirmed objective disease progression, death, and study termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start17 Mar 2023
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Zhengang Yuan, PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital, Navy Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013943
- Sponsor's protocol ID
- EHBHKY2022-H040-P001
- Status last verified
- Sep 2023
- First submitted
- 12 Apr 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Envafolimab Combined With GEMOX in First-line Treatment of Advanced Gallbladder Cancer : A Single Center, Single Arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT06013943
- Acronym / sponsor ID
- EHBHKY2022-H040-P001
- Conditions
- Gallbladder Cancer
- Keywords
- Envafolimab(immune checkpoint inhibitor anti-PD-L1 antibody)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TOPAZ-1 study compared the advantages and disadvantages of immune checkpoint inhibitor anti-PD-L1 antibody combined with Gem/Cis chemotherapy (Gemcitabine and Cisplatin) and Gem/Cis chemotherapy alone in first-line treatment of advanced biliary tract tumors (BTC, which including gallbladder cancer). It was observed that chemotherapy combined with PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS).
As a standard first-line chemotherapy regimen for BTC too, Gemox chemotherapy (gemcitabine and cisplatin) has a median OS of 9.5 months, and non-inferior survival time to Gem/Cis chemotherapy. In addition, Gemox chemotherapy has been widely used in clinical practice because it reduces the requirement on patients' renal function and has good tolerance. Envafolimab is a novel fusion of humanized mono-domain PD-L1 antibody and human IgG Fc fragment, which has shown good efficacy and safety in a variety of solid tumors. It is safe and convenient to administer by subcutaneous injection. However, there is currently no clinical data on Envafolimab combined with GEMOX chemotherapy in patients with advanced gallbladder cancer (GBC).
The goal of this clinical trial is to evaluate its efficacy and related safety in patients with GBC. Eligible participants will receive Envafolimab (up to 12 months) plus gemcitabine and cisplatin (up to 6-8 cycles) until progression of radiological disease, unacceptable toxicity, or withdrawal from the study, whichever comes first.The primary endpoint was the 6-month PFS rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab+Gemox | Experimental | Drug: Envafolimab+Gemox |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Definite diagnosis of gallbladder carcinoma by histology or cytology；
- There is at least one measurable lesion (according to RECIST1.1);
- From 18 to 75 years old, ECOG physical strength score of 0-2;
- Basically normal bone marrow function: neutrophils >1.5x10^9/L, platelets >100x10^9/L;
- Adequate renal function: creatinine clearance > 60ml/min;
Key exclusion criteria (14 listed)
- Previous systematic therapy, including chemotherapy, immunotherapy and targeted therapy;
- Secondary malignancies or other neoplasms (except superficial skin cancer and localized low-grade malignancies) occurring in the 3 years prior to study initiation;
- The presence of brain or meningeal metastasis;
- Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc. );
- Have received allogeneic organ transplantation (eg kidney transplantation, liver transplantation, heart transplantation, etc. );
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envafolimab+GemoxAll of drugs were used for 6-8 cycles at the combined treatment stage, then Envafolimab and Gemcitabine continued at maintenance treatment stage until disease progression as defined by RECIST1.1, unacceptable toxicity, withdrawal from the study or death, or no more than 1 years. Combined treatment stage: Envafolimab(150mg, iH, Q1W, Day1)+Gemcitabine(1000mg/m2, iv, Q3W, Day1 and Day8)+Cisplatin(1000mg/m2, iv, Q3W, Day1 and Day8); Caintenance treatment stage: Envafolimab(400mg, iH, Day1, Q3W)+Gemcitabine(1000mg/m2, po, Day1-14, Q3W). | Drug | Envafolimab+Gemox |
Primary outcome
6-month progression-free survival rate (PFS)
Time frame: 6 months
Defined as the rate of patients had no disease progression or death (whichever occurred first) from the start of treatment to 6 months after treatment.
4 secondary outcomes
Progression free survival (PFS)
Time frame: Up to two years
Overall survival (OS)
Time frame: Up to two years
Disease control rate (DCR) per RECIST 1.1
Time frame: Once every 3 weeks (±7 days) from the first day of Envafolimab treatment for a maximum of 2 years until confirmed objective disease progression, death, and study termination.
Objective response rate (ORR) per RECIST 1.1
Time frame: Once every 3 weeks (±7 days) from the first day of Envafolimab treatment for a maximum of 2 years until confirmed objective disease progression, death, and study termination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengang Yuan, PhD principal investigator
Eastern Hepatobiliary Surgery Hospital, Navy Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab+Gemox in people with Gallbladder Cancer, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengang Yuan, PhD (+86-021-81887453, yuanzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival rate (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.