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

NCT05149807 | Terminated Phase 2

• 1 other identifier: SHR-1701-III-308
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Phase II : Pathological Complete Response pCR rate.

  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.

  Up to approximately 23 months

• Phase III : Event-free Survival (EFS)

  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.

  Up to approximately 57 months

Secondary Outcomes (7)

• Disease-free Survival (DFS).

  Up to approximately 57 months

• Preoperative Objective Response Rate (ORR).

  Up to approximately 57 months

• Major pathological response (MPR) rates.

  Up to approximately 23 months

• R0 resection rate

  Up to approximately 23 months

• Overall Survival (OS).

  Up to approximately 57 months

Study Arms (2)

SHR-1701 + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin

EXPERIMENTAL

Drug: SHR-1701 injection

Placebo + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1701 injection DRUG

SHR-1701 injection Tegafur Gimeracil Oteracil Potassium Oxaliplatin

SHR-1701 + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin

Placebo DRUG

Placebo Tegafur Gimeracil Oteracil Potassium Oxaliplatin

Placebo + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-1.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (20)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

The Second Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Southern Medical University NanFang Hospital

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Xingtai People's Hospital

Xingtai, Hebei, 054031, China

Location

Anyang Cancer Hospital

Anyang, Henan, 455000, China

Location

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, 471003, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Subei people's Hospital of Jiangsu Province

Yangzhou, Jiangsu, 225001, China

Location

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, 110801, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

The Second Affiliated Hospital of Air Force Military University Tangdu Hospital

Xi’an, Shanxi, 7100038, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610042, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

SHR-1701

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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; 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.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 8, 2021
• Study Start: January 26, 2022
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: August 20, 2025

Record last verified: 2024-07

Locations

CN (20)