Esophagogastric Junction AdenocarcinomaPhase 2AEGISNCT06482788
Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study
A Phase 2 study testing Adebrelimab (anti-PD-L1) + XELOX in people with Esophagogastric Junction Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagogastric Junction Adenocarcinoma
- What is being tested?
- Adebrelimab (anti-PD-L1) + XELOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2024to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Sign on the informed consent form (ICF)
- Histologically confirmed esophagogastric junction Adenocarcinoma (AEG, Type Siewert I/II/ III), the stage is locally advanced cT1b-2N+ or T3-4Nany that the investigator judges it to be resectable (1. CT or MRI assessment shows no invasion of adjacent organs or tissues, 2. No peritoneal metastasis occurs, 3. There are surgical indications) (Note: If bone lesions are suspected, a bone scan is required; if peritoneal carcinomatosis is suspected, laparoscopy is required to confirm; if T3-T4 subjects have diffuse tissue types, diagnostic laparoscopy is also required))
- No previous systematic treatment
- At least one measurable lesion according to RECIST 1.1.
- ECOG PS: 0-1
- The functions of important organs meet the following requirements：Absolute neutrophil count ≥ 1.5 × 109/L； Platelet ≥ 100 × 109/L； Hemoglobin ≥ 90g / l; ALT and AST ≤ 2.5 times ULN; TBIL ≤ 1.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60ml / min; INR ≤ 1.5, APTT ≤ 1.5 times ULN; No obvious abnormality on electrocardiogram.
- Male subjects and women of childbearing age must take contraceptive measures from the first dose to the last 3 months of use of the study drug.
Who cannot join
- Histologically confirmed Squamous cell carcinoma or mixed type.
- Distant metastasis: If peritoneal cancer or ascites is suspected by imaging, histological or cytological confirmation such as laparoscopic exploration is required.
- Medical history and complications: 1.Having contraindications to surgical resection of esophagogastric junction cancer 2.Having any known active autoimmune diseases 3.Having any complications that require systemic treatment with glucocorticoids such as prednisone (>10 mg/day) or have used immunosuppressive drugs within 14 days before the first dose
- Having received tumor vaccines or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within 1 month before the first dose 4.Having participated in other clinical trials or have received drug interventions from other clinical trials within 4 weeks before the first dose 5.Having other malignant tumors that need treatment 6.Having a history of severe cardiovascular disease 7.Having a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Severe allergic reaction to drugs (Adbrelimab, Capecitabine, Oxaliplatin).
- The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive; Hepatitis C reference: HCV antibody positive.
- According to the judgment of the researcher, the subject has other factors that may lead to the forced midway termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Hecheng Li, MD,PHD, 021-64370045, lihecheng2000@hotmail.com
Chengqiang Li, MD,PHD, 13524282905, whipple@yeah.net
About this study
The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.
Read the detailed description
The study will evaluate the efficacy and safety of the immunotherapy (Adebrelimab) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma. Potential study participants will be assessed for eligibility during a 28-day screening period that includes central verification of clinical stage and eligibility. Eligible patients will be receive perioperative treatment with adebrelimab with XELOX. Location of the primary (GEJ type I vs. GEJ type II/III vs. stomach), and PD-L1-status (CPS≥5 vs. CPS<5). Microsatellite Instability (MSI-H vs MSI-L) will be will be given special attention.
- Conditions
- Esophagogastric Junction Adenocarcinoma
- Being tested
- Adebrelimab (anti-PD-L1) + XELOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab (anti-PD-L1) + XELOXDrug
Adebrelimab: 1200mg, i.v., each infusion lasts 30-60 minutes and is administered on the first day of each cycle (3 weeks).
Capecitabine: 1000mg/m2 , bid, orally, from day 1 to day 14 of each cycle (3 weeks).
Oxaliplatin: 130mg/m2, i.v., each infusion is administered on the first day of each cycle (3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients will receive Immunotherapy (Adebrelimab, PD-L1 inhibitor) combined with XELOX chemotherapy (Capecitabine + Oxaliplatin) therapy in four 3-week treatment cycles with imaging assessment every 2 cycles. After treatment response evaluation, patients will receive resection within 4-8 weeks. Following surgery, patients will receive four further 3-week cycles of Adebrelimab + XELOX after 4-12 weeks of resection. Patients will then receive 10 additional 3-week treatment cycles with Adebrelimab alone. Receives: Drug: Adebrelimab (anti-PD-L1) + XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (ITT)
The proportion of subjects with no cancer cells in the primary tumor and lymph node specimens (ypT0N0)
Measured: From date of enrolment until surgical resection, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start22 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagogastric Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482788
- Sponsor's protocol ID
- RTS-023
- Acronym
- AEGIS
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Cao Y, Wang X, Li C, Zhao L, Li H. Effects of perioperative treatment of resectable adenocarcinoma of esophagogastric junction by immunotherapy (Adebrelimab) combined with chemotherapy (XELOX): protocol for a single-center, open-labeled study (AEGIS trial, neoadjuvant immunochemotherapy). BMC Cancer. 2025 Feb 4;25(1):198. doi: 10.1186/s12885-025-13589-z.
PubMed 39905364
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study
- ClinicalTrials.gov ID
- NCT06482788
- Acronym / sponsor ID
- AEGIS / RTS-023
- Conditions
- Esophagogastric Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Jul 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 purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.
Detailed description
The study will evaluate the efficacy and safety of the immunotherapy (Adebrelimab) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma. Potential study participants will be assessed for eligibility during a 28-day screening period that includes central verification of clinical stage and eligibility. Eligible patients will be receive perioperative treatment with adebrelimab with XELOX. Location of the primary (GEJ type I vs. GEJ type II/III vs. stomach), and PD-L1-status (CPS≥5 vs. CPS<5). Microsatellite Instability (MSI-H vs MSI-L) will be will be given special attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Adebrelimab (anti-PD-L1) + XELOXPatients will receive Immunotherapy (Adebrelimab, PD-L1 inhibitor) combined with XELOX chemotherapy (Capecitabine + Oxaliplatin) therapy in four 3-week treatment cycles with imaging assessment every 2 cycles. After treatment response evaluation, patients will receive resection within 4-8 weeks. Following surgery, patients will receive four further 3-week cycles of Adebrelimab + XELOX after 4-12 weeks of resection. Patients will then receive 10 additional 3-week treatment cycles with Adebrelimab alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sign on the informed consent form (ICF)
- Histologically confirmed esophagogastric junction Adenocarcinoma (AEG, Type Siewert I/II/ III), the stage is locally advanced cT1b-2N+ or T3-4Nany that the investigator judges it to be resectable (1. CT or MRI assessment shows no invasion of adjacent organs or tissues, 2. No peritoneal metastasis occurs, 3. There are surgical indications) (Note: If bone lesions are suspected, a bone scan is required; if peritoneal carcinomatosis is suspected, laparoscopy is required to confirm; if T3-T4 subjects have diffuse tissue types, diagnostic laparoscopy is also required))
- No previous systematic treatment
- At least one measurable lesion according to RECIST 1.1.
- ECOG PS: 0-1
Key exclusion criteria (7 listed)
- Histologically confirmed Squamous cell carcinoma or mixed type.
- Distant metastasis: If peritoneal cancer or ascites is suspected by imaging, histological or cytological confirmation such as laparoscopic exploration is required.
- Medical history and complications: 1.Having contraindications to surgical resection of esophagogastric junction cancer 2.Having any known active autoimmune diseases 3.Having any complications that require systemic treatment with glucocorticoids such as prednisone (>10 mg/day) or have used immunosuppressive drugs within 14 days before the first dose
- Having received tumor vaccines or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within 1 month before the first dose 4.Having participated in other clinical trials or have received drug interventions from other clinical trials within 4 weeks before the first dose 5.Having other malignant tumors that need treatment 6.Having a history of severe cardiovascular disease 7.Having a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Severe allergic reaction to drugs (Adbrelimab, Capecitabine, Oxaliplatin).
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 (anti-PD-L1) + XELOXAdebrelimab: 1200mg, i.v., each infusion lasts 30-60 minutes and is administered on the first day of each cycle (3 weeks). Capecitabine: 1000mg/m2 , bid, orally, from day 1 to day 14 of each cycle (3 weeks). Oxaliplatin: 130mg/m2, i.v., each infusion is administered on the first day of each cycle (3 weeks). | Drug | Experimental arm |
Primary outcome
Pathological complete response rate (ITT)
Time frame: From date of enrolment until surgical resection, an average of 3 months
The proportion of subjects with no cancer cells in the primary tumor and lymph node specimens (ypT0N0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 39905364Li Y, Cao Y, Wang X, Li C, Zhao L, Li H. Effects of perioperative treatment of resectable adenocarcinoma of esophagogastric junction by immunotherapy (Adebrelimab) combined with chemotherapy (XELOX): protocol for a single-center, open-labeled study (AEGIS trial, neoadjuvant immunochemotherapy). BMC Cancer. 2025 Feb 4;25(1):198. doi: 10.1186/s12885-025-13589-z.
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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.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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 (anti-PD-L1) + XELOX in people with Esophagogastric Junction Adenocarcinoma, run by Ruijin 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (ITT) (time frame: From date of enrolment until surgical resection, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06482788, which also lists 1 linked publication.
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 1 Jul 2024.