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Tests treatment safety and results for Stomach Neoplasms
Official title Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
ClinicalTrials.gov ID: NCT06576921
What this study is testing
What is Serplulimab Combined With Chemotherapy?
Serplulimab Combined With Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stomach neoplasms.
Also referred to as Nap-paclitaxel, S-1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG. The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age older than 18 and younger than 75 years
- Primary GC or AEG (Siewert II/III)confirmed pathologically by endoscopic biopsy
- Clinical stage T3/T4N+M0 disease as assessed by CT/MRI, PET-CT, and laparoscopy, if feasible
- At least one measurable lesion according to the RECIST, version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You likely can't join if
- Squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma, and undifferentiated gastric cancer were confirmed by pathology
- Positive Her-2 detection (IHC3+ or IHC2+ amplified by FISH detection)
- Prior chemotherapy, radiotherapy, hormone therapy, targeted therapy, or immunotherapy
- Contraindications for surgical treatment or chemotherapy
- Presence of distant metastasis
- History of other malignant disease within the past 5 years, except: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ...
See the full eligibility criteria
- Age older than 18 and younger than 75 years
- Primary GC or AEG (Siewert II/III)confirmed pathologically by endoscopic biopsy
- Clinical stage T3/T4N+M0 disease as assessed by CT/MRI, PET-CT, and laparoscopy, if feasible
- At least one measurable lesion according to the RECIST, version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Surgical treatment after neoadjuvant chemotherapy is planned according to clinical staging criteria.
- Life expectancy of at least 3 months
- Acceptable bone marrow, hepatic, and renal function, including: a)Blood routine examination(No blood transfusion within 14 days; No granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulating...
- Written informed consent
- Squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma, and undifferentiated gastric cancer were confirmed by pathology
- Positive Her-2 detection (IHC3+ or IHC2+ amplified by FISH detection)
- Prior chemotherapy, radiotherapy, hormone therapy, targeted therapy, or immunotherapy
- Contraindications for surgical treatment or chemotherapy
- Presence of distant metastasis
- History of other malignant disease within the past 5 years, except: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that have been treated radically and have shown no...
- Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for people with vitiligo or resolved childhood asthma/atopy
- History of immunodeficiency diseases, including human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or transplantation
- Severe mental disorder
- Presence of digestive tract obstruction, jaundice, acute infectious diseases, inflammatory bowel disease, Crohn's disease, ulcerative colitis, chronic diarrhea, active tuberculosis
- Immunosuppressive drugs are required for 2 weeks or within 2 weeks or during the study period, excluding the following: a) intranasal, inhaled, topical or topical steroid injections (e.g. intra-articular injections); b)...
- Patients who have undergone major surgery or received live virus vaccine within 4 weeks
- Pregnant or breast-feeding women, people who are unwilling to receive effective contraception during treatment and within 6 months after the end of treatment (including male people who have the ability to impregnate...
- Evidence of bleeding tendency or receiving thrombolytics or anticoagulants
- According to the criteria of the term Common Adverse Events (NCI-CTCAE V5.0), the corresponding symptoms have been diagnosed;
- Hepatitis B or hepatitis C virology tests at the time of screening meet any of the following: a) HBsAg positive and HBV-DNA titer ≥104 copy number /mL or ≥2000IU/mL (hepatitis B carriers should ask researchers for...
- Allergic to study drugs
- The investigator believes that the people have other conditions that may affect their adherence to the protocol and evaluation of the study indicators, and the people are not suitable to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Heibei Province, China
- Xi'an, Shaanxi, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Heibei Province, China; Xi'an, Shaanxi, China; Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.