UnknownPhase 2

Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer

China24 participantsStarted 2023-03-09

Plain-language summary

This is a single-center, open phase II clinical trial to evaluate the tolerability, safety and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Platelet (PLT) count ≥ 90\*109/L.
✓. Neutrophil count (ANC) ≥ 1.5\*109/L.
✓. Hemoglobin (Hb) level ≥ 9.0 g/dl.
✓. International normalized ratio (INR) ≤ 1.5.
✓. Prothrombin time (PT) and active partial thromboplastin time (APTT) ≤ 1.5 x ULN.
✓. Glycated hemoglobin (HbA1c) \<7.5%.
✓. Total bilirubin (TBIL) level ≤ 1.5 times the upper limit of normal (ULN).
✓. Alanine amino transaminase (ALT) and aspartate amino transaminase (AST) levels ≤ 2.5 x ULN.

Exclusion criteria

✕. Previously received chemotherapy, radiotherapy or immunotherapy for gastric cancer
✕. Previously diagnosed any other malignancy with a primary site or histological type different from gastric cancer within 5 years prior to study entry, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
✕. With known hypersensitivity to the study drug or excipients, or to similar drugs
✕. Received major surgery or open biopsy, or had a major trauma within 4 weeks prior to the start of study treatment
✕. Received immunosuppressive drugs (excluding inhaled corticosteroids or ≤10 mg/day prednisone or equivalent pharmacophysiologic doses of other systemic steroids) within 2 weeks prior to the start of study treatment
✕. Planned live attenuated vaccination within 4 weeks prior to the start of study treatment or during the study period
✕. Inability to discontinue CYP3A4 inducers or inhibitors within 1 week prior to the start of study treatment and during the study period
✕. Presence of any autoimmune disease or history of autoimmune disease.

What they're measuring

Pathological complete remission (pCR) rates

Timeframe: 12 weeks

Trial details

NCT IDNCT05994456

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Dongsheng Zhang, PhD

86-2087343795 zhangdsh@sysucc.org.cn

View on ClinicalTrials.gov More Gastric or Gastroesophageal Junction Adenocarcinoma trials