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Neoadjuvant Propranolol Plus SOX and Toripalimab for Locally Advanced Gastric/GEJ Adenocarcinoma

NCT07727993 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-07-27

No results posted yet for this study

Summary

This is a single-center, prospective, open-label, single-arm, phase Ib/II study evaluating the safety and efficacy of neoadjuvant propranolol combined with SOX chemotherapy and toripalimab in patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 49 participants will be enrolled. Stage 1 includes an initial safety lead-in of 12 participants, followed by efficacy evaluation using a Simon two-stage design. Participants will receive propranolol, toripalimab, oxaliplatin, and S-1 during the neoadjuvant period, followed by curative-intent surgery.

The primary efficacy endpoint is pathological complete response. Secondary endpoints include safety and tolerability, major pathological response, R0 resection rate, event-free survival, recurrence-free survival, and overall survival. Exploratory analyses will assess changes in adrenergic stress markers, heart rate variability, peripheral immune parameters, β-adrenergic receptor signaling, and the tumor immune microenvironment.

Conditions

  • Gastric or Gastroesophageal Junction Adenocarcinoma
  • Propranolol
  • SOX Chemotherapy
  • Toripalimab

Interventions

DRUG

propranolol

Propranolol will be administered orally at 10 mg twice daily beginning on Day 1 of the first neoadjuvant treatment cycle. The dose may be reduced to 5 mg twice daily, temporarily interrupted, or discontinued according to tolerability and predefined safety criteria, including heart rate, blood pressure, respiratory symptoms, and cardiac conduction abnormalities. Propranolol may be continued during postoperative treatment until completion of adjuvant therapy or the occurrence of unacceptable toxicity.

DRUG

Toripalimab

Toripalimab will be administered intravenously at a fixed dose of 240 mg on Day 1 of each 21-day cycle. Participants will receive 3 neoadjuvant cycles before surgery. After surgery, 3 additional cycles are recommended, followed by toripalimab maintenance as clinically appropriate for a total immunotherapy duration of up to 1 year from the first dose.

DRUG

Oxaliplatin

Oxaliplatin will be administered intravenously at 130 mg/m² on Day 1 of each 21-day cycle. Participants will receive 3 neoadjuvant cycles before surgery. Three additional postoperative cycles are recommended according to postoperative recovery, tolerability, and the investigator's assessment. Dose modification, interruption, or discontinuation will be permitted for treatment-related toxicity.

DRUG

S-1

S-1 will be administered orally twice daily on Days 1-14 of each 21-day cycle, followed by a 7-day rest period. The total daily dose will be determined according to body surface area: 80 mg/day for body surface area below 1.25 m², 100 mg/day for body surface area of 1.25-1.49 m², and 120 mg/day for body surface area of 1.50 m² or greater. Participants will receive 3 neoadjuvant cycles, with 3 additional postoperative cycles recommended according to tolerability and postoperative recovery.

Sponsors & Collaborators

  • Ting Liu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-06-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727993 on ClinicalTrials.gov