Health Condition 1: C155- Malignant neoplasm of lower thirdof esophagus Health Condition 2: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: Arm A: Toripalimab Plus CAPOX: A)Toripalimab:
Dosage: 240 mg administered intravenously on Day 1 of each treatment cycle.
Frequency: Every 3 weeks (Q3W).
B)CAPOX Chemotherapy:
1.Oxalipl
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants must be male or female and at least 18 years old when they provide documented informed consent. 2. Participants must have a histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, with known PD-L1 expression status. 3. PD-L1 CPS equal to or more than 10 and or MSI-H 4.Participants must have HER2 negative cancer, defined as IHC score of 0 or positive 1) or FISH negative (HER2 ratio less than 2 with an average HER2 copy number less than 4.0 signals per cell). Locally available ISH methods may be used as per institutional guidelines. 5. Male participants must agree to refrain from donating sperm and either remain abstinent or use contraception during the study and for at least 95 days after the last dose of chemotherapy. 6. Female participants must not be pregnant or breastfeeding and must agree to use effective contraception if of childbearing potential (WOCBP), with pregnancy testing required before study participation. 7. Participants must provide written informed consent for the study, with optional consent for future biomedical research. 8. Participants must have measurable disease per RECIST 1.1 criteria as assessed by the investigator. 9. Participants must have an ECOG performance status of 0 or 1 within 3 days before starting the study intervention. 10. Participants must have adequate organ function as defined by study-specific laboratory criteria
Exclusion criteria
Exclusion criteria: 1. Participants with squamous cell or undifferentiated gastric cancer. 2. Participants who have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or who anticipate needing major surgery during the study. Participants must have recovered adequately from prior surgery. 3. Participants with preexisting peripheral neuropathy greater than Grade 1. 4. Women of childbearing potential (WOCBP) with a positive pregnancy test within 72 hours prior to randomization. 5. Participants with prior therapy for locally advanced, unresectable, or metastatic gastric/GEJ cancer, unless neoadjuvant/adjuvant therapy was completed at least 6 months before randomization. 6. Participants with prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy, or other T-cell receptor-targeting therapies (e.g., CTLA-4, OX-40, CD137). 7. Participants able to afford immune checkpoint inhibitors (ICIs) such as PD-1 inhibitors (Nivolumab, Pembrolizumab, and Cemiplimab), PDL-1 inhibitors (Atezolimumab, Durvalumab and Avelumab), and CTLA-4 inhibitors (Ipilimumab) as a standard of care will be excluded from the study. 8. Participants with prior systemic anticancer therapy within 4 weeks before randomization 9. Participants with prior radiotherapy within 2 weeks before starting the study, unless it was used for palliative radiation to non-CNS disease. 10. Participants who have received a live or live-attenuated vaccine within 30 days before the first dose. 11. Participants currently in or recently participated in an interventional clinical study within 4 weeks prior to the first dose. 12. Participants with immunodeficiency or those receiving chronic systemic steroids (dose more than 10 mg prednisone equivalent) or immunosuppressive therapy within 7 days before the first dose. 13. Participants with a progressing malignancy or requiring active treatment within the past 5 years (except certain skin carcinomas or carcinoma in situ). 14. Participants with known active CNS metastases or carcinomatous meningitis, unless previously treated and stable without steroids for at least 14 days. 15. Participants with severe hypersensitivity (equal to or more than Grade 3) to Toripalimab or its excipients. 16. Participants with active autoimmune disease requiring systemic treatment in the past 2 years (except replacement therapy). 17. Participants with a history of (non-infectious) pneumonitis requiring steroids or current pneumonitis. 18. Participants with active infection requiring systemic therapy. 19. Participants with a known history of HIV infection. 20. Participants with a known history of active and uncontrolled Hepatitis B or C infection. 21. Participants with a history of active tuberculosis. 22. Participants with any condition or laboratory abnormality that might interfere with study results or participation. 23. Participants with a psychiatric or substance abuse disorder that would interfere with study requirements. 24. Pregnant or breastfeeding participants, or those expecting to conceive or father children during the study and follow-up period. 25. Participants with a history of allogenic tissue/solid organ transplant. 26. Participants with severe hypersensitivity (more than or equal to Grade 3) to study chemotherapy agents or excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS)Timepoint: the time from the time of diagnosis of an advanced disease to the time of disease progression or loss to follow-up or death, whichever is earlier or at the end of 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS)Timepoint: defined as the time from the time of diagnosis to the time of death, lost to follow-up or last observation at the end of 12 Months;Objective response (OR)Timepoint: evaluated as per RECIST criteria at 6 months from the date of randomisation;side effects and adverse event profile with the combinationTimepoint: meausered at the end of trial;quality of life assessmentTimepoint: at baseline and every two month till study participation | — |
Countries
India
Contacts
Public ContactDr Vikas Ostwal
Tata Memorial Hospital
Outcome results
None listed