NCT06374901Not yet recruitingPhase 2
Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment.
A Multicenter, Prospective Phase II Clinical Study of Tislelizumab in Combination With Chemotherapy for the Perioperative Treatment of Resectable Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 19 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 15 Apr 2024
- Start date
- 25 Apr 2024
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Xiangdong Cheng
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06374901
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 134
- From 25 Apr 2024 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- There are non resectable factors, including tumor reasons that cannot be resected or surgical contraindications that cannot be resected or those who refuse surgery
- Previously or currently suffering from other malignant tumors
- If there are significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, within the first 3 months prior to the first use of the study drug, and if fecal occult blood is positive during the baseline period, a follow-up examination can be conducted. If the results are still positive after the follow- up examination, a gastroscopy examination is required (excluding those who have undergone gastroscopy examination within 3 months prior to enrollment to exclude such situations)
- Planned or previously received organ or allogeneic bone marrow transplantation
- Current or recent use of immunosuppressive drugs or systemic corticosteroids for the purpose of achieving immunosuppression
- Patients who have received attenuated live vaccines within 28 days prior to the first use of the study drug, or who need to receive such vaccines during treatment or within 60 days after the last dose
- Known to be allergic to any investigational drug or excipient
Other illness
- Suffering from any chronic or major illness that is considered intolerable to treatment (such as severe heart disease, uncontrolled hypertension, certain degrees of liver and kidney dysfunction, etc.)
- Those who have experienced gastrointestinal perforation, abdominal abscess in the past, or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms indicating accompanying intestinal obstruction
- If the patient is in the active infection stage and needs treatment (such as using antibiotics, antiviral drugs, or antifungal drugs)
- Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number\>upper limit of normal value)
- Patients with congenital or acquired immune dysfunction (such as HIV infected individuals)
- Patients with any active autoimmune diseases or a history of autoimmune diseases with the possibility of recurrence
- Subjects who currently have interstitial pneumonia or interstitial lung disease, or have a history of requiring hormone therapy for interstitial pneumonia or interstitial lung disease, or those whose screening period CT shows active pneumonia or severe lung function impairment; Active pulmonary tuberculosis
Other
- Lactating women
- Any factors determined by the researcher that may affect patient safety and result in the forced termination of this study midway
Who the study is looking for
- The patient voluntarily joined this study and signed an informed consent form;
- Age ≥ 18 years old, ≤ 75 years old
- Pathological diagnosis of gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction
- Patients must be able to provide fresh slices of tumor tissue (FFPE tissue blocks or approximately 15 slides), unstained FFPE slides, and if clinically feasible, fresh biopsy samples will be preferred. If archived samples cannot be obtained, fresh tumor biopsy specimens must be collected during the baseline period, with the same requirements for glass slides as archived tumor tissue
- Clinical staging determined by CT and laparoscopy for curative resection is cT3\~4aN+M0 or cT4bNanyM0 for gastric and gastroesophageal junction adenocarcinoma patients (according to AJCC 8th edition staging)
- Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)
- Plan to undergo surgical treatment after the completion of neoadjuvant therapy
- Able to swallow pills normally
- ECOG score 0-1 points
- Expected survival time ≥ 12 months
- Normal function of major organs, i.e. meeting the following criteria:The standard for blood routine examination must comply with: (No blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors),Neutrophil absolute count ≥ 1.5 × 109/L; Platelets ≥ 80 × 109/L; Hemoglobin ≥ 80g/L
- Biochemical examination must meet the following standards: Total bilirubin\<1.5
- ULN; ALT and AST ≤ 2.5 × ULN; Serum Cr ≤ 1.5 x ULN or endogenous creatinine clearance rate\>50ml/min (male: endogenous creatinine clearance rate=(140 age) x body weight)/(72 x serum Cr); Female: Endogenous creatinine clearance rate=(140 age) x body weight/(72 x serum Cr) x 0.85; Weight unit: kg; Serum Cr unit: mg/mL
- Female subjects with pregnancy ability must undergo a serum pregnancy test within 7 days before the first medication, and the result is negative. They are willing to use efficient contraception methods during the trial period and 120 days after the last dose. For male subjects whose partners are women of childbearing age, surgical sterilization or agreement to use efficient methods of contraception during the trial period and 120 days after the last dose should be considered
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.