NCT05149807终止2 期
A Randomized, Double-Blind, Multi-Center Phase II/III Clinical Study of PD-L1 Antibody/TGF-βRII (SHR-1701) Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin Versus Placebo Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin as Perioperative Treatment in Subjects With Resectable Gastric Cancer or Gastroesophageal Junction Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 81
- 试验地点
- 20
- 主要终点
- Phase II : Pathological Complete Response pCR rate.
研究概览
简要总结
This is a multi-center phase II/III clinical study consisting of two stages: Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin mainly by the endpoint of pCR rate.
Stage II is a randomized, double-blind, multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC. A total of 846 treatment naïve subjects will be enrolled, and primary endpoint of this stage is Independent Review Committee (IRC)-assessed EFS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed with GC or GEJC, histologically confirmed to be adenocarcinoma, and have no previous anti-tumor treatments for GC or GEJC.
- •Aged 18 or above, male or female.
- •Be suitable for (investigator's assessment) and planning to undergo neoadjuvant therapy + radical surgery with curative intent before entering into the study.
- •locally advanced Gastric Cancer or Gastroesophageal Junction Cancer confirmed by investigator.
- •Be able to provide tumor tissue blocks.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Life expectancy of ≥ 6 months.
- •Have adequate organ and bone marrow functions.
- •Women without childbearing potential refer to post-menopausal women, or women who underwent bilateral oophorectomy with medical records. Male subjects and female subjects of childbearing potential must agree to take a medically approved contraceptive measure (refer to Appendix 4) during the study, within 3 months after the last dose of investigational product (SHR-1701), and within 9 months after the last dose of chemotherapy agents (S-1 and oxaliplatin); have a negative serum pregnancy test result within 3 days prior to the start of study treatment and not be breastfeeding.
- •Subjects must agree and have signed the informed consent form, be willing and able to follow the scheduled visits, study treatment, laboratory tests, and other study procedures.
排除标准
- •Have known squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with gastric cancer of other histological types.
- •Have unresectable factors, including unresectable tumors or contraindications to surgery or refusal of surgery.
- •Have more than 20% weight loss within 2 months prior to enrollment or randomization.
- •Have previously received some treatments or medications including anti-tumor treatments.
- •Diagnosed with other malignant tumors within 5 years prior to enrollment.
- •Have any active, known, or suspected autoimmune disease.
- •Have clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment or randomization; have gastrointestinal perforation and/or gastrointestinal fistula within 6 months prior to enrollment or randomization; have arterial/venous thrombotic events within 6 months prior to enrollment or randomization.
- •Have major vascular disease within 6 months prior to enrollment or randomization.
- •Have severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
- •Have intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to enrollment or randomization.
- •Have interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic disease.
- •Have known allergies to the study drug or their excipients; have severe allergic reactions to other monoclonal antibodies.
- •Have HIV infection or known AIDS, active untreated hepatitis or co-infection with hepatitis B and C.
- •Have uncontrolled cardiac symptoms or disease:
- •Have received systemic antibiotics for ≥ 7 days within 4 weeks prior to enrollment or randomization, or have unexplained fever > 38.5 °C during screening or before the first dose.
- •Have known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Have been screened for other clinical studies but failed the screening because PD-L1 expression did not meet the inclusion criteria or met the exclusion criteria; have participated in clinical studies of any other drugs, less than 4 weeks or 5 half-lives of the drug between the last dose of these study treatments and enrollment/randomization for this study (whichever is longer).
- •Have a known history of psychotropic substance abuse or drug abuse.
- •Have other severe physical or psychiatric disorders or laboratory abnormalities, which may increase the risk of participation in this study or interfere with the study results, or deemed unsuitable by the investigator.
研究组 & 干预措施
SHR-1701 + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin
Experimental
干预措施: SHR-1701 injection (Drug)
Placebo + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Phase II : Pathological Complete Response pCR rate.
时间窗: Up to approximately 23 months
pCR rate is defined as the proportion of subjects whose specimens (including primary lesion and lymph nodes) obtained during GC or GEJC radical surgery are pathologically assessed to be free of residual live tumor cells after neoadjuvant therapy.
Phase III : Event-free Survival (EFS)
时间窗: Up to approximately 57 months
EFS is defined as time from randomization to PD or death (whichever occurs first), detailed that tumor progression/recurrence or new lesion confirmed by RECIST v1.1 criteria or death due to any cause.
次要结局
- 30-day postoperative mortality.(Up to approximately 24 months)
- Overall Survival (OS).(Up to approximately 57 months)
- Disease-free Survival (DFS).(Up to approximately 57 months)
- Preoperative Objective Response Rate (ORR).(Up to approximately 57 months)
- Percentage of Participants Who Experience One or More Adverse Events (AEs).(Up to approximately 57 months)
- Major pathological response (MPR) rates.(Up to approximately 23 months)
- R0 resection rate(Up to approximately 23 months)
研究者
研究点 (20)
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