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Recruiting NCT07464756

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

Phase II Interventional Gastric Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1701, apatinib, S-1 & Oxaliplatin.
Who it may be relevant to
Registry conditions: Gastric Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug SHR-1701
    SHR-1701, 1800mg, Q3w
  • Drug apatinib
    apatinib 250mg，Q3W
  • Drug S-1 & Oxaliplatin
    S-1, Oxaliplatin, Q3w

Primary outcome measures

  • Pathological Complete Response (pCR) [Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
Secondary outcome measures (7)
  • Tumor Regression Grade (TRG) [Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
  • ypN staging [Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
  • R0 resection rate [Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
  • Event free survival (EFS) [Time frame: Up to approximately 4 years]
  • Disease-free survival (DFS) [Time frame: Up to approximately 4 years]
  • Overall survival(OS) [Time frame: Up to approximately 4 years]
  • AEs [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • Patients voluntarily participate in this study and provide signed informed consent;
  • Age ≥18 years old;
  • Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
  • Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
  • No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
  • Plan to proceed to surgery after completion of neoadjuvant therapy;
  • Able to swallow tablets normally;
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • Estimated life expectancy ≥12 months;
  • Has adequate organ function.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.

Exclusion criteria

  • Known HER2 positive
  • Need transthoracic surgical approach Based on the investigator's judgment
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT07464756 · MA-GC-II-028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗