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SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer | Clinical Trials | Clareo Health

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SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer

A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07464756•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Detailed Description

This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1：SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients voluntarily participate in this study and provide signed informed consent;
•2. Age ≥18 years old;
•3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
•4. Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
•5. No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
•6. Plan to proceed to surgery after completion of neoadjuvant therapy;
•7. Able to swallow tablets normally;
•8. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
•9. Estimated life expectancy ≥12 months;
•10. Has adequate organ function.
+1 more criteria

Exclusion Criteria

•1. Known HER2 positive
•2. Need transthoracic surgical approach Based on the investigator's judgment
•3. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;
•5\. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. Congenital or acquired immune deficiency (e.g. HIV infected)

Key Dates

Start Date

April 5, 2026

Primary Completion Date

May 31, 2028

Completion Date

July 31, 2030

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

Gastric Adenocarcinoma

Interventions

SHR-1701

DRUG

apatinib

DRUG

S-1 & Oxaliplatin

DRUG

A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

NCT06901531

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or Cancer+2 more

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RECRUITINGPHASE3

mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma

NCT05677490

Advanced Esophageal AdenocarcinomaAdvanced Gastric Adenocarcinoma+13 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma

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Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study

Registry Platform Gastric/Esophageal Cancer (SAPHIR)