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Compares treatment options for Gastric Cancer
Official title Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT05918094
What this study is testing
What is Experimental dose: modified XELOX + sintilimab?
Experimental dose: modified XELOX + sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
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 randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Have a good understanding of the study, are willing to follow the requirements of the study, and voluntarily sign the informed consent form.
- Aged ≥ 18 years old and ≤ 75 years old.
- Locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma confirmed by pathological histology or cytology.
- No previous systemic therapy. Note: Patients who have previously received neoadjuvant or adjuvant therapy may be enrolled if they have ended...
- Agree to provide a previously stored tumor tissue sample or a biopsy to collect tumor tissue.
You likely can't join if
- Prior exposure to any immune checkpoint inhibitors (anti-PD-1 antibody, anti-PD-L1 antibody, CTLA-4 antibody).
- Receiving antitumor cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin 2 or interferon), or other...
- Receiving radiotherapy within 4 weeks prior to the first dose.
- Have undergone major surgical surgery within 4 weeks prior to enrollment or have not fully recovered from previous surgery.
- Known presence of symptomatic CNS metastases and/or carcinomatous meningitis. people with prior treatment for brain metastases may participate in the...
- A history of other primary malignancies, except: malignancies in complete response for at least 2 years prior to enrollment and requiring no other...
See the full eligibility criteria
- Have a good understanding of the study, are willing to follow the requirements of the study, and voluntarily sign the informed consent form.
- Aged ≥ 18 years old and ≤ 75 years old.
- Locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma confirmed by pathological histology or cytology.
- No previous systemic therapy. Note: Patients who have previously received neoadjuvant or adjuvant therapy may be enrolled if they have ended treatment without recurrence or disease progression for at least 6 months.
- Agree to provide a previously stored tumor tissue sample or a biopsy to collect tumor tissue.
- ECOG PS score is in the range of 0\~1.
- Expected survival time ≥ 3 months.
- people having adequate organ and bone marrow functions with laboratory test values within 7 days prior to enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other...
- Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; platelet count (PLT) ≥ 75×10\^9/L; hemoglobin level (HGB) ≥ 7.5 g/dL.
- Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN in people without liver metastases, and ALT and AST ≤ 5.0...
- Renal function: serum creatinine (Cr) ≤ 1.5 x ULN, or creatinine clearance\>50 mL/min.
- Female people of childbearing age or male people whose sexual partners are at childbearing age are required to take effective contraception measures throughout the treatment period and for 6 months after the treatment
- Prior exposure to any immune checkpoint inhibitors (anti-PD-1 antibody, anti-PD-L1 antibody, CTLA-4 antibody).
- Receiving antitumor cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin 2 or interferon), or other investigational treatments within 4 weeks prior to enrollment.
- Receiving radiotherapy within 4 weeks prior to the first dose.
- Have undergone major surgical surgery within 4 weeks prior to enrollment or have not fully recovered from previous surgery.
- Known presence of symptomatic CNS metastases and/or carcinomatous meningitis. people with prior treatment for brain metastases may participate in the study provided that the brain metastases have remained stable for at...
- A history of other primary malignancies, except: malignancies in complete response for at least 2 years prior to enrollment and requiring no other treatment during the study period; adequately treated non-melanoma skin...
- Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine...
- A history of gastrointestinal perforation and/or fistula in the previous 6 months.
- Presence of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition).
- Confirmed as HER2-positive (i.e., IHC 3+ or IHC 2+ with ISH+) gastric or gastroesophageal adenocarcinoma.
- Have heart symptoms or diseases that are not well controlled, such as:
- Have had NYHA grade 3 or 4 cardiac insufficiency within 6 months prior to enrollment;
- Unstable angina;
- Have had acute myocardial infarction within 6 months prior to enrollment;
- Have had clinically significant arrhythmias within 6 months prior to enrollment requiring treatment or intervention.
- Infected with human immunodeficiency virus (HIV) (HIV 1/2 antibody or HIV RNA positive).
- Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA ≥ 1000 copies/mL) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive).
- Severe infections that are in the active phase or poorly controlled in clinical practice. Serious infection, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia...
- A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- A history of allergy or known intolerance to any drug in the study regimen.
- Receiving live attenuated vaccine within 4 weeks prior to the first dose or planning to receive during the study period.
- The toxicity of previous antitumor therapy has not returned to grade 0-1 according to CTCAE 5.0.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanchang, Jiangxi, China
- Dalian, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Kunming, Yunnan, 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 Guangzhou, Guangdong, China; Guiyang, Guizhou, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Nanchang, Jiangxi, China and 4 more location(s). 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.