Status:
UNKNOWN
Nab-PTX Plus S-1 and Sintilimab as Adjuvant Therapy in Patients With Stage IIIC Gastric Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Stage IIIC Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
In this study, we combine Nab-PTX, S-1 and sintilimab as adjuvant regimen to patients with stage IIIC GC. We are aiming to investigate the recommended dose of this regimen in a phase I study and estim...
Detailed Description
The phase I study is a dose-escalation study using a standard 3+3 design. The regimen involves 3-week cycles with escalated doses of nab-paclitaxel (80-120 mg/m2 on days 1 and 8) and fixed doses of si...
Eligibility Criteria
Inclusion
- 18 years to 80 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Primary gastric cancer or gastroesophageal junction cancer that is pathologically diagnosed as adenocarcinoma;
- Patients who have underwent radical resection with D2 lymphadenectomy and histologically proven to be stage IIIC gastric cancer according to the 8th edition of the UICC/AJCC TNM staging system for gastric cancer\[29\];
- Patients who have received no prior chemotherapy or radiotherapy or immunotherapy for gastric cancer or gastroesophageal junction cancer;
- No peritoneal metastasis by laparoscopy and no tumor cells in peritoneal fluid on cytologic analysis;
- Adequate organ function for chemotherapy as follows:
- absolute neutrophil count of ≥1.5×109/L;
- platelet count of ≥100×109/L;
- hemoglobin ≥90g/L;
- bilirubin of \<1.5×upper limit of normal \[ULN\];
- alanine aminotransferase and aspartate aminotransferase of \<2.5×ULN;
- serum creatinine of ≤1.5×ULN;
- creatinine clearance of \>50 mL/min;
- TSH ≤1×ULN (if abnormal, T3 and T4 levels should be inspected at the same time, if T3 and T4 levels are normal, they can be included in the group);
- APTT ≤1.5×ULN and INR ≤1.5×ULN;
- myocardial enzymogram ≤1×ULN.
- Written (signed) informed consent;
- Good compliance with the study procedures, including examination and treatment;
- Surgeons should have experience doing this type of surgery (\>50 procedures per year);
- Patients have recovered from the operation and have no unresolved postoperative complications (such as postoperative infection, anastomotic leakage, gastrointestinal bleeding, pancreatic leakage) during baseline evaluation;
- Start first treatment between 4 weeks and 12 weeks after surgery and there is no potential disease recurrence at the baseline evaluation;
- The serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group for the female patients of non-surgical sterilization or childbearing age;
- During the study treatment period and within 3 months after the end of the study treatment period, a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom) should be used for the enrolled patients.
Exclusion
- Distant metastatic disease evaluated by Chest-abdomen-pelvis CT, bone scan and head MR when with central nervous system symptoms or PET-CT;
- R1 or R2 surgical margins;
- Hospital stays exceeding 60 days;
- Patients with history of prior or concurrent malignant tumors. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible;
- Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials);
- Patients with serious complications such as:
- Uncontrolled cardiovascular disease, angina and arrhythmia;
- Myocardial infarction in past six months;
- Uncontrolled diabetes mellitus.
- History of receiving anti-PD-1, anti-PD-L1, anti-PD-L2 or any other T cell co-simulation or checkpoint inhibitor therapy (eg. CTLA-4, OX-40, CD137);
- Received any anti-cancer for this disease, including chemotherapy or radiotherapy or immunotherapy or Chinese traditional herb therapy;
- Refuse to provide blood/tissue sample;
- Female patients who are pregnant or lactating, or planning to become pregnant or lactating;
- Active autoimmune disease or history of refractory autoimmune disease; Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
- Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;
- Uncontrollable pleural effusion, pericardial effusion or ascites;
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Patients with history of hypersensitivity to any drugs in this study;
- It may affect the absorption of S-1 in patients with upper gastrointestinal obstruction /bleeding, abnormal digestive function or malabsorption syndrome;
- Have not fully recovered from toxicity or complications caused by any intervention before starting treatment;
- HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time).
- Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period;
- Severe or uncontrolled systemic disease:
- severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ level II, uncontrolled arrhythmia and myocardial infarction within 12 months before admission;
- active infection which requires systemic treatment;
- active tuberculosis;
- central nervous system (CNS) disorder or peripheral nervous system disorder or psychiatric disease;
- history of primary immunodeficiency;
- complicated with severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury.
- Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04781413
Start Date
March 1 2021
End Date
March 1 2024
Last Update
March 4 2021
Active Locations (1)
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1
Department of Surgery, Ruijin Hospital
Shanghai, China, 200025