Clinical Study of SHR-1701 Plus Chemotherapy as Perioperative Treatment in Subjects With Gastric Cancer

Phase 2

Terminated

• Conditions: Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer

• Registration Number: NCT05149807
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Pathologically diagnosed with GC or GEJC, histologically confirmed to be<br> adenocarcinoma, and have no previous anti-tumor treatments for GC or GEJC.<br><br> 2. Aged 18 or above, male or female.<br><br> 3. Be suitable for (investigator's assessment) and planning to undergo neoadjuvant<br> therapy + radical surgery with curative intent before entering into the study.<br><br> 4. locally advanced Gastric Cancer or Gastroesophageal Junction Cancer confirmed by<br> investigator.<br><br> 5. Be able to provide tumor tissue blocks.<br><br> 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.<br><br> 7. Life expectancy of = 6 months.<br><br> 8. Have adequate organ and bone marrow functions.<br><br> 9. Women without childbearing potential refer to post-menopausal women, or women who<br> underwent bilateral oophorectomy with medical records. Male subjects and female<br> subjects of childbearing potential must agree to take a medically approved<br> contraceptive measure (refer to Appendix 4) during the study, within 3 months after<br> the last dose of investigational product (SHR-1701), and within 9 months after the<br> last dose of chemotherapy agents (S-1 and oxaliplatin); have a negative serum<br> pregnancy test result within 3 days prior to the start of study treatment and not be<br> breastfeeding.<br><br> 10. Subjects must agree and have signed the informed consent form, be willing and able<br> to follow the scheduled visits, study treatment, laboratory tests, and other study<br> procedures.<br><br>Exclusion Criteria:<br><br> 1. Have known squamous cell carcinoma, undifferentiated carcinoma, or other<br> histological types of gastric cancer, or adenocarcinoma mixed with gastric cancer of<br> other histological types.<br><br> 2. Have unresectable factors, including unresectable tumors or contraindications to<br> surgery or refusal of surgery.<br><br> 3. Have more than 20% weight loss within 2 months prior to enrollment or randomization.<br><br> 4. Have previously received some treatments or medications including anti-tumor<br> treatments.<br><br> 5. Diagnosed with other malignant tumors within 5 years prior to enrollment.<br><br> 6. Have any active, known, or suspected autoimmune disease.<br><br> 7. Have clinically significant bleeding symptoms or clear bleeding tendency within 3<br> months prior to enrollment or randomization; have gastrointestinal perforation<br> and/or gastrointestinal fistula within 6 months prior to enrollment or<br> randomization; have arterial/venous thrombotic events within 6 months prior to<br> enrollment or randomization.<br><br> 8. Have major vascular disease within 6 months prior to enrollment or randomization.<br><br> 9. Have severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.<br><br> 10. Have intestinal obstruction and/or clinical signs or symptoms of gastrointestinal<br> obstruction within 6 months prior to enrollment or randomization.<br><br> 11. Have interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic<br> disease.<br><br> 12. Have known allergies to the study drug or their excipients; have severe allergic<br> reactions to other monoclonal antibodies.<br><br> 13. Have HIV infection or known AIDS, active untreated hepatitis or co-infection with<br> hepatitis B and C.<br><br> 14. Have uncontrolled cardiac symptoms or disease:<br><br> 15. Have received systemic antibiotics for = 7 days within 4 weeks prior to enrollment<br> or randomization, or have unexplained fever > 38.5 °C during screening or before the<br> first dose.<br><br> 16. Have known history of allogeneic organ transplantation or allogeneic hematopoietic<br> stem cell transplantation.<br><br> 17. Have been screened for other clinical studies but failed the screening because PD-L1<br> expression did not meet the inclusion criteria or met the exclusion criteria; have<br> participated in clinical studies of any other drugs, less than 4 weeks or 5<br> half-lives of the drug between the last dose of these study treatments and<br> enrollment/randomization for this study (whichever is longer).<br><br> 18. Have a known history of psychotropic substance abuse or drug abuse.<br><br> 19. Have other severe physical or psychiatric disorders or laboratory abnormalities,<br> which may increase the risk of participation in this study or interfere with the<br> study results, or deemed unsuitable by the investigator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase II : Pathological Complete Response pCR rate.;Phase III : Event-free Survival (EFS)

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS).;Preoperative Objective Response Rate (ORR).;Major pathological response (MPR) rates.;R0 resection rate;Overall Survival (OS).;Percentage of Participants Who Experience One or More Adverse Events (AEs).;30-day postoperative mortality.