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New treatment option for Disorder in Complete Remission in Response to Treatment
Official title Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma
ClinicalTrials.gov ID: NCT05563012
What this study is testing
What is Sintilimal Injection?
Sintilimal Injection is an investigational medicine, being studied as a potential treatment for disorder in complete remission in response to treatment.
Also referred to as Capecitabine, Oxaliplatin.
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 Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant therapy for locally advanced gastric adenocarcinoma.
- Phase 2: a mid-size study of how well it works
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
- All individuals recruited signed a written informed consent;
- Aged between 18 and 75 years;
- Histologically confirmed gastric adenocarcinoma, and Stage III (cT3-4aN1-3 M0, American Joint Committee on Cancer (AJCC) TNM staging system 8th...
- No previous systemic therapy, including including surgery, radiotherapy, chemotherapy and immunotherapy, etc；
- Patients who have no contraindications and consent to radical surgery;
You likely can't join if
- Other malignancy disease history within five years, with the exception of basal cell carcinoma or squamous carcinoma of skin, and carcinoma in situ...
- Endoscopic signs of active bleeding in the lesion;
- Is participating in an treatment clinical study or has received another study drug or used a study device within 4 weeks before the first study drug...
- Prior treatment with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor...
- Systemic systemic therapy with Chinese patent drugs or immunomodulatory agents (including thymosin, interferon, and interleukin, except for local use...
- Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying agents, glucocorticoids, or immunosuppressants) occurred within...
See the full eligibility criteria
- All individuals recruited signed a written informed consent;
- Aged between 18 and 75 years;
- Histologically confirmed gastric adenocarcinoma, and Stage III (cT3-4aN1-3 M0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cawas confirmed by enhanced CT/MRI scan (endoscopic...
- No previous systemic therapy, including including surgery, radiotherapy, chemotherapy and immunotherapy, etc；
- Patients who have no contraindications and consent to radical surgery;
- Eastern Cooperative Group (ECOG) performance status score 0 or 1;
- Expected survival time \> 6 months;
- The main organ function of cases should be normal, and meet the following criteria: ①Absolute neutrophil count (ANC)≥1.5×109/L (no Granulocyte colony-stimulating factor within 14 days prior to enrolment); ②Platelets...
- Female people of reproductive age must conduct pregnancy test (serum or urine) within 3 days before the first study drug administration (day 1 of cycle 1), and the results are negative. If the urine pregnancy test...
- If there was a risk of conception, all people (male or female) were required to use contraception with an annual failure rate of less than 1% for the entire treatment period until 120 days after the last administration...
- Other malignancy disease history within five years, with the exception of basal cell carcinoma or squamous carcinoma of skin, and carcinoma in situ that have undergone radical resection;
- Endoscopic signs of active bleeding in the lesion;
- Is participating in an treatment clinical study or has received another study drug or used a study device within 4 weeks before the first study drug administration;
- Prior treatment with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. CTLA-4, OX40, CD137) drugs;
- Systemic systemic therapy with Chinese patent drugs or immunomodulatory agents (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) with anti-tumor indications was received...
- Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying agents, glucocorticoids, or immunosuppressants) occurred within 2 years before the first study drug administration. Replacement...
- Had received systemic glucocorticoid therapy (excluding nasal, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first study drug administration;
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known allergy to drugs used in this study;
- Unable to intake Capecitabine orally (such as the inability to swallow and intestinal obstruction);
- Failure to recover from treatment-related toxicity/complications to baseline or grade-1 AEs (except for fatigue and hair loss);
- Has a known history of HIV infection (HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg-positive with a detected HBV-DNA copy number greater than the upper limit of normal values in the laboratory at the study center); Note: Hepatitis B people who meet the...
- Active HCV-infected people (HCV antibody positive with HCV-RNA levels higher then the lower limit of detection);
- Had received live vaccine within 30 days before the first study drug administration; Note: Inactivated virus vaccine for injection against seasonal influenza is permitted for 30 days before the first study drug...
- Pregnant or lactating women;
- The presence of any severe or uncontrolled systemic disease, e.g; ①The resting ECG showed significant abnormalities in rhythm, conduction or morphology with severe symptoms and difficult to control, such as complete...
- people are not eligible to participate in the study if they have abnormal medical history or evidence of disease, treatment or laboratory test values that may interfere with the results of the trial or prevent their...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Wuhan, Hubei, 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.