Gastroesophageal Junction AdenocarcinomaPhase 2SNACRTNCT05918419
Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction
A Phase 2 study testing Serplulimab in people with Gastroesophageal Junction Adenocarcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Investigators conduct the clinical trial to further explore the efficacy and safety of Neoadjuvant chemoradiation Plus Serpluimab in Patients with locally advanced Adenocarcinoma of Gastroesophageal Junction Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Serplulimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Sep 2024
- 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
- histologically documented adenocarcinoma of Gastroesophageal Junction.
- clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan.
- Male or female. Age ≥ 18 years and ≤75 years.
- surgeons participating in this study consider the lesion a resectable one.
- ECOG 0~1
- Physical condition and adequate organ function to ensure the success of abdominal surgery.
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- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN . ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
- Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Female patients should not be pregnant or breast feeding.
- PD-L1 assessment
Who cannot join
- patients with distant metastasis or unresectable primary lesion.
- patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy.
- history of chemo, radiation, immune therapy or radical resection for the GEJ.
- patients with active autoimmune disease or history of refractory autoimmune disease.
- patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
- uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment.
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- patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
- perforation / fistula of GI tract in 6 months before recruitment.
- patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of S-1.
- losing over 20% body weight in 2 months before recruitment.
- pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease.
- uncontrollable systemic diseases, including diabetes, hypertension, etc.
- severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc.
- patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA.
- patients with any cardiovascular risk factors below:
- cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity.
- pulmonary embolism with symptoms occurring in 28 days before recruitment.
- acute myocardial infarction occurring in 6 months before recruitment.
- any history of heart failure reaching grade 3/4 of NYHA in 6 months before recruitment.
- ventricular arrhythmias of Grade 2 or grater in 6 months before recruitment, or accompanied by supraventricular tachyarrhythmias requiring medical treatment.
- cerebrovascular accident within 6 months before recruitment.
- patients with peripheral neuropathy NCI CTC AE grade 1, except those with only deep tendon reflex disappearing.
- moderate or severe renal injury [creatinine clearance rate≤50 ml/min (according to Cockroft \& Gault equation)], or Scr>1.5 x ULN.
- dipyrimidine dehydrogenase (DPD) deficiency.
- allergic to any drug in this study.
- history of allogeneic stem cell transplantation or organ transplantation.
- use of steroids (dosage>10mg/d prednisone) or other systemic immune suppressive therapy in 14 days before recruitment, except patients treated with regimens below: a. steroids for hormone replacement (dosage>10mg/d prednisone); b. steroids for local application with little systemic absorption; c. short -term (≤ 7 days) steroids for preventing allergy or vomiting.
- vaccinated with live vaccine in 4 weeks before recruitment.
- receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment.
- receiving palliative radiation in 14 days before recruitment.
- history of anti PD-1, PD-L1, PD-L2 or any other specific T cell co-stimulation or checkpoint pathway targeted treatment.
- receiving operation in 28 days before recruitment, only if the operation is a minimally invasive one e.g. PICC.
- for patients with uncontrolled epilepsy, CNS diseases or history of mental disorder, researchers should evaluate whether their diseases will impede their signing of informed consent or compliance of treatment.
- existing of potential situation which will impede drug administration or affect toxicity analysis or alcohol/ drug abuse.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Zhao Lin, MD, 010-69156874, wz20010727@aliyun.com
About this study
Official title: Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction: a Single-arm,Open-label，Phase II Clinical Study
Investigators conduct the clinical trial to further explore the efficacy and safety of Neoadjuvant chemoradiation Plus Serpluimab in Patients with locally advanced Adenocarcinoma of Gastroesophageal Junction
Read the detailed description
- Target population: patients with locally advanced adenocarcinoma of Gastroesophageal Junction (cT3-4aN+M0).
- Primary objective: pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus Serpluimab in patients with locally advanced Adenocarcinoma of Gastroesophageal Junction
- Patients will be given the perioperative treatment as below once recruited: induction chemotherapy ：Serplulimab 300mg iv.gtt d1+Oxaliplatin130mg/m2 iv.gtt d1,+S1 40mg/m2 p.o.b.i.d. d1~d14（up to 60mg) .Every three weeks for one cycle. After the induction chemotherapy，concurrent chemoradiation will be strated：Serplulimab 300mg iv.gtt d1,+Oxaliplatin100mg/m2 iv.gtt d1+S1 40mg/m2 p.o.b.i.d. d1~d14(up to 60mg), every three weeks , the total of two cycles . Radiation total dose: 45Gy/25F, 1.8Gy/d. Resectable patients will receive D2 resection After 6-8weeks Neoajuvant therapy
- Number of subjects: 35 patients. Number of centers: 1 site(Peking Union Medical College Hospital)
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Being tested
- Serplulimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoradiation | Experimental | neoadjuvant chemoradiation plus PD-1 antibody (Serplulimab) Intervention: Drug: Neoadjuvant chemoradiation plus PD-1 antibody(Serpluimab) Receives: Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete regression (pCR) rate
pathological complete remission (pCR) rate of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction
Measured: 3 months after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Feb 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918419
- Sponsor's protocol ID
- 2023-GEJ-IIT
- Acronym
- SNACRT
- Status last verified
- Jan 2023
- First submitted
- 4 Jun 2023
- Last updated
- 26 Jun 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 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction: a Single-arm,Open-label，Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05918419
- Acronym / sponsor ID
- SNACRT / 2023-GEJ-IIT
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 26 Jun 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.
Investigators conduct the clinical trial to further explore the efficacy and safety of Neoadjuvant chemoradiation Plus Serpluimab in Patients with locally advanced Adenocarcinoma of Gastroesophageal Junction
Detailed description
- Target population: patients with locally advanced adenocarcinoma of Gastroesophageal Junction (cT3-4aN+M0).
- Primary objective: pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus Serpluimab in patients with locally advanced Adenocarcinoma of Gastroesophageal Junction
- Patients will be given the perioperative treatment as below once recruited: induction chemotherapy ：Serplulimab 300mg iv.gtt d1+Oxaliplatin130mg/m2 iv.gtt d1,+S1 40mg/m2 p.o.b.i.d. d1~d14（up to 60mg) .Every three weeks for one cycle. After the induction chemotherapy，concurrent chemoradiation will be strated：Serplulimab 300mg iv.gtt d1,+Oxaliplatin100mg/m2 iv.gtt d1+S1 40mg/m2 p.o.b.i.d. d1~d14(up to 60mg), every three weeks , the total of two cycles . Radiation total dose: 45Gy/25F, 1.8Gy/d. Resectable patients will receive D2 resection After 6-8weeks Neoajuvant therapy
- Number of subjects: 35 patients. Number of centers: 1 site(Peking Union Medical College Hospital)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoradiation | Experimental | Drug: Serplulimabneoadjuvant chemoradiation plus PD-1 antibody (Serplulimab) Intervention: Drug: Neoadjuvant chemoradiation plus PD-1 antibody(Serpluimab) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- histologically documented adenocarcinoma of Gastroesophageal Junction.
- clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan.
- Male or female. Age ≥ 18 years and ≤75 years.
- surgeons participating in this study consider the lesion a resectable one.
- ECOG 0~1
Key exclusion criteria (35 listed)
- patients with distant metastasis or unresectable primary lesion.
- patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy.
- history of chemo, radiation, immune therapy or radical resection for the GEJ.
- patients with active autoimmune disease or history of refractory autoimmune disease.
- patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
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 |
|---|---|---|
| SerplulimabPD-1 antibody | Drug | Neoadjuvant Chemoradiation |
Primary outcome
Pathological complete regression (pCR) rate
Time frame: 3 months after the last subject participating in
pathological complete remission (pCR) rate of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
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 Serplulimab in people with Gastroesophageal Junction Adenocarcinoma, run by Peking Union Medical College 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 15 inclusion and 35 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 26 Jun 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 Zhao Lin (010-69156874, wz20010727@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete regression (pCR) rate (time frame: 3 months after the last subject participating in). 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 26 Jun 2023.