AdebrelimabPhase 2NCT06198465
Perioperative Adebrelimab and Chemotherapy in Esophageal and Esophagogastric Junction Carcinoma
A Phase 2 study testing adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil in people with Adebrelimab and Esophageal Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
The goal of this prospective, open-label, single-center clinical study is to learn about the efficacy and safety of aderbelimab combined with chemotherapy in the perioperative treatment of esophageal and esophagogastric junction cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adebrelimab, Esophageal Cancer, Perioperative Period
- What is being tested?
- adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2024to 30 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years, both genders;
- Histologically or cytological confirmed esophageal and esophagogastric junction cancer (cT3-4, anyN, M0);
- Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment for esophageal and esophagogastric junction cancer;
- According to the RECIST v1.1 standard, there must be at least 1 measurable lesion;
- ECOG PS score 0-1;
- Adequate organ function, and there are no serious functional abnormalities or immune deficiency diseases such as blood, heart, lung, liver, kidney, bone marrow, etc. Laboratory examinations meet the following requirements:
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- 1) Hemoglobin ≥ 90 g/L; 2) Leukocytes ≥ 3.0x10^9/L; Absolute neutrophil count≥ 1.5x10^9/L; 3) Platelet ≥ 100x10^9/L; 4) Serum creatinine ≤1.5 ULN or creatinine clearance rate≥50 mL/min; 5) Total bilirubin ≤1.5 ULN; 6) ALT ≤2.5 ULN; AST ≤2.5 ULN; 7) Urinary protein <2+; if urine protein≥2+, 24-hour urine protein quantification shows that the protein must be ≤1g; 7. Coagulation function test:
- INR ≤1.5 ULN;
- APTT ≤1.5 ULN;
- PT≤1.5ULN； 8.Previous use of anti-tumor traditional Chinese medicines, Chinese patent medicines, and immunomodulators (such as thymosin, interleukins, etc.) must be ≥ 2 weeks from the start of study medication; 9. For females of child bearing potential, a negative serum/urine pregnancy test result within 72h before study treatment. For female and male participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study; 10.Volunteered to participate in the study, signed the informed consent form; 11. Had good compliance and cooperated with the follow-up.
Who cannot join
- Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) can be included after treatment); subjects with childhood asthma that has completely resolved and do not require any intervention in adulthood or vitiligo can be included, but subjects who require medical intervention with bronchodilators are not included;
- People with innate or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C positive hepatitis C antibody, and high HCV-RNA (lower detection limit of the analytical method) or combined with hepatitis B and hepatitis C co-infection; patients who have used other drugs for clinical trial research within 4 weeks before the first dose;
- Have had clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months;
- Such as gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, bleeding gastric ulcer, or vasculitis; a gastroscopy is required during the screening period. If the gastroscopy results indicate severe gastric ulcer or the researcher determines that there is bleeding, If the risk is high, you will not be eligible; gastrointestinal perforation or gastrointestinal fistula has occurred within 6 months;
- Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II or above heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia;
- The number of neutrophils in peripheral blood <1500/mm3;
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- Severe infection (e.g. requiring intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first dose, or unexplained fever >38.5°C during the screening period/before the first dose;
- Those who are known to have a history of allergies to the drug components of this regimen;
- There may be increased risks of participation in research and study medication, or other severe, acute and chronic diseases;
- Other conditions deemed inappropriate for inclusion by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, the Air Force Medical University
Xi'an, Shaan'xi, 710032
About this study
Official title: Perioperative Adebrelimab and Chemotherapy in Esophageal and Esophagogastric Junction Carcinoma: a Prospective, Open-label, Single-center Clinical Study
The goal of this prospective, open-label, single-center clinical study is to learn about the efficacy and safety of aderbelimab combined with chemotherapy in the perioperative treatment of esophageal and esophagogastric junction cancer. The main question it aims to answer are:prediction for pCR after perioperative adebrelimab and chemotherapy in esophageal and esophagogastric junction carcinoma
- Conditions
- Adebrelimab, Esophageal Cancer, Perioperative Period
- Being tested
- adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adebrelimab,Paclitaxel,Lobaplatin,FluorouracilDrug
adebrelimab: 1200mg，D1，q3w; Paclitaxel: 50mg/m2 D1/8/15； Lobaplatin: 50mg，iv 2h，d1; Fluorouracil: 400mg/m2，bolus iv，600mg/m2，iv 22h，d1-3；
| Study group | Role | What they receive |
|---|---|---|
| adebrelimab combined with chemotherapy | Experimental | Not described Receives: Drug: adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory
Measured: At time of surgery
Secondary outcomes (4)
R0 resection rate
R0 resection rate
Measured: At time of surgery
Disease-Free Survival (DFS)
Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death
Measured: up to 2 year
Overall Survival (OS)
defined as the time from randomization to death from any cause during the course of the study.
Measured: up to 2 year
Number of participants with treatment-related adverse events
assessed by CTCAE v4.03
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdebrelimabStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198465
- Sponsor's protocol ID
- XJEC
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Adebrelimab and Chemotherapy in Esophageal and Esophagogastric Junction Carcinoma: a Prospective, Open-label, Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT06198465
- Acronym / sponsor ID
- XJEC
- Conditions
- Adebrelimab, Esophageal Cancer, Perioperative Period
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Jan 2024 (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 goal of this prospective, open-label, single-center clinical study is to learn about the efficacy and safety of aderbelimab combined with chemotherapy in the perioperative treatment of esophageal and esophagogastric junction cancer. The main question it aims to answer are:prediction for pCR after perioperative adebrelimab and chemotherapy in esophageal and esophagogastric junction carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adebrelimab combined with chemotherapy | Experimental | Drug: adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged ≥18 years, both genders;
- Histologically or cytological confirmed esophageal and esophagogastric junction cancer (cT3-4, anyN, M0);
- Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment for esophageal and esophagogastric junction cancer;
- According to the RECIST v1.1 standard, there must be at least 1 measurable lesion;
- ECOG PS score 0-1;
Key exclusion criteria (10 listed)
- Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) can be included after treatment); subjects with childhood asthma that has completely resolved and do not require any intervention in adulthood or vitiligo can be included, but subjects who require medical intervention with bronchodilators are not included;
- People with innate or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C positive hepatitis C antibody, and high HCV-RNA (lower detection limit of the analytical method) or combined with hepatitis B and hepatitis C co-infection; patients who have used other drugs for clinical trial research within 4 weeks before the first dose;
- Have had clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months;
- Such as gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, bleeding gastric ulcer, or vasculitis; a gastroscopy is required during the screening period. If the gastroscopy results indicate severe gastric ulcer or the researcher determines that there is bleeding, If the risk is high, you will not be eligible; gastrointestinal perforation or gastrointestinal fistula has occurred within 6 months;
- Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II or above heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia;
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 |
|---|---|---|
| adebrelimab,Paclitaxel,Lobaplatin,Fluorouraciladebrelimab: 1200mg，D1，q3w; Paclitaxel: 50mg/m2 D1/8/15； Lobaplatin: 50mg，iv 2h，d1; Fluorouracil: 400mg/m2，bolus iv，600mg/m2，iv 22h，d1-3； | Drug | adebrelimab combined with chemotherapy |
Primary outcome
Pathological Complete Response (pCR)
Time frame: At time of surgery
defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory
4 secondary outcomes
R0 resection rate
Time frame: At time of surgery
Disease-Free Survival (DFS)
Time frame: up to 2 year
Overall Survival (OS)
Time frame: up to 2 year
Number of participants with treatment-related adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
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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.
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 adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil in people with Adebrelimab and Esophageal Cancer, run by Xijing 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 10 inclusion and 10 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 10 Jan 2024. 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 Liu Hong, MD,PhD (13709284513, hongliu180@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: At time of surgery). 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 10 Jan 2024.