Gastric AdenocarcinomaPhase 2NCT06496789
Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
A Phase 2 study testing Serplulimab+SOX in people with Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Serplulimab+SOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2023to 31 Dec 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 Gastric or Gastroesophageal Junction. 2. clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan. 3. Male or female. Age ≥ 18 years and ≤75 years. 4. surgeons participating in this study consider the lesion a resectable one. 5. ECOG 0~1 6. Physical condition and adequate organ function to ensure the success of abdominal surgery. 7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L. 8. 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. 9. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min. 10. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN. 11. No serious concomitant disease that will threaten the survival of patients to less than 5 years. 12. Written (signed) informed consent. 13. Good compliance with the study procedures, including lab and auxiliary examination and treatment. 14. Female patients should not be pregnant or breast feeding. 15. PD-L1 assessment
Who cannot join
- patients with distant metastasis or unresectable primary lesion. 2. patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy. 3. history of chemo, radiation, immune therapy or radical resection for the GC/GEJ. 4. patients with active autoimmune disease or history of refractory autoimmune disease. 5. 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. 6. uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment. 7. patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding. 8. perforation / fistula of GI tract in 6 months before recruitment. 9. patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of S-1. 10. losing over 20% body weight in 2 months before recruitment. 11. pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease. 12. uncontrollable systemic diseases, including diabetes, hypertension, etc. 13. severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc. 14. patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA. 15. 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. 16. patients with peripheral neuropathy NCI CTC AE grade 1, except those with only deep tendon reflex disappearing. 17. moderate or severe renal injury [creatinine clearance rate≤50 ml/min (according to Cockroft \& Gault equation)], or Scr>1.5 x ULN. 18. dipyrimidine dehydrogenase (DPD) deficiency. 19. allergic to any drug in this study. 20. history of allogeneic stem cell transplantation or organ transplantation. 21. 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. 22. vaccinated with live vaccine in 4 weeks before recruitment. 23. receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment. 24. receiving palliative radiation in 14 days before recruitment. 25. history of anti PD-1, PD-L1, PD-L2 or any other specific T cell costimulation or checkpoint pathway targeted treatment. 26. receiving operation in 28 days before recruitment, only if the operation is a minimally invasive one e.g. PICC. 27. 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
hongjie zhan, MD, 022-23109106, hongjiezhan@163.com
About this study
Official title: Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer: a Single-arm Phase 2 Trial
evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Serplulimab+SOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab+SOXDrug
Serplulimab+Oxaliplatin+S1
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Not described Receives: Drug: Serplulimab+SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR
Pathological complete regression rate
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 posted11 Jul 2024
- Study start27 May 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Model description
- Drug:Serplulimab+Oxaliplatin+S-1
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496789
- Sponsor's protocol ID
- HLX10IIT12-TJMUCH
- Status last verified
- Jun 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- 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 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer: a Single-arm Phase 2 Trial
- ClinicalTrials.gov ID
- NCT06496789
- Acronym / sponsor ID
- HLX10IIT12-TJMUCH
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 27 May 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 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.
evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Drug:Serplulimab+Oxaliplatin+S-1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Drug: Serplulimab+SOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically documented adenocarcinoma of Gastric or Gastroesophageal Junction. 2. clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan. 3. Male or female. Age ≥ 18 years and ≤75 years. 4. surgeons participating in this study consider the lesion a resectable one. 5. ECOG 0~1 6. Physical condition and adequate organ function to ensure the success of abdominal surgery. 7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L. 8. 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. 9. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min. 10. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN. 11. No serious concomitant disease that will threaten the survival of patients to less than 5 years. 12. Written (signed) informed consent. 13. Good compliance with the study procedures, including lab and auxiliary examination and treatment. 14. Female patients should not be pregnant or breast feeding. 15. PD-L1 assessment
Key exclusion criteria (7 listed)
- patients with distant metastasis or unresectable primary lesion. 2. patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy. 3. history of chemo, radiation, immune therapy or radical resection for the GC/GEJ. 4. patients with active autoimmune disease or history of refractory autoimmune disease. 5. 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. 6. uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment. 7. patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding. 8. perforation / fistula of GI tract in 6 months before recruitment. 9. patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of S-1. 10. losing over 20% body weight in 2 months before recruitment. 11. pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease. 12. uncontrollable systemic diseases, including diabetes, hypertension, etc. 13. severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc. 14. patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA. 15. patients with any cardiovascular risk factors below:
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 |
|---|---|---|
| Serplulimab+SOXSerplulimab+Oxaliplatin+S1 | Drug | Neoadjuvant chemotherapy |
Primary outcome
PCR
Time frame: 3 months after the last subject participating in
Pathological complete regression rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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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+SOX in people with Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and 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 1 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: status not confirmed, as of the sponsor's last update on 11 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hongjie zhan (18622228706, hongjiezhan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR (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 11 Jul 2024.