NCT06728657

Preoperative HFRT Verses PULSAR for Locally Advanced GEJ or Proximal Gastric Adenocarcinoma

A Phase II Randomized Trial of Preoperative Hypofractionated Radiotherapy (HFRT) Compared to Personalized Hyperfractionated Stereotactic Adaptive Radiotherapy (PULSAR), Combined With Chemotherapy and PD-1 Monoclonal Antibody for Locally Advanced Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of the multimodal treatment, which includes radiotherapy, chemotherapy and anti-PD-1 immunotherapy. The trial is designed using a pick-the-winner strategy. The main questions it aims to answer are: 1. If the multimodal treatment will improve the pCR rate. 2. If the multimodal treatment can be performed safely. 3. Hypofractionated radiotherapy (HFRT) or personalized hyperfractionated stereotactic adaptive radiotherapy (PULSAR), which pattern of radiotherapy can better synergize with immunotherapy. Participants will receive HFRT or PULSAR for the primary lesion and positive lymph nodes, combined with CAPOX and anti-PD-1 immunotherapy. Then, reassessment will be performed within 4 weeks afterwards. For resectable participants, surgical resections will be performed. Postoperative treatment will be determined by the investigators. For unresectable or inoperable participants, the subsequent treatment will be determined by investigators or MDT.

Conditions

• Stomach Adenocarcinoma
• Gastro-esophageal Junction Cancer

Interventions

Type	Name	Description
RADIATION	HFRT targeted to the primary lesion and positive lymph nodes	Hypofractionated radiotherapy (HFRT) targeted to the primary lesion and positive lymph nodes (4Gy × 6 fractions)
RADIATION	PULSAR targeted to the primary lesion and positive lymph nodes	Irradiation targeted to the primary lesion and positive lymph nodes (6 Gy/1 fraction)
DRUG	Anti-PD-1 monoclonal antibody	The anti-PD-1 mAb is used on day 1 along with each cycle of chemotherapy. There are no restrictions on the choice of anti-PD-1 mAb. Patients can choose commonly used accessible monoclonal antibodies based on their personal preferences and financial status. The commonly used anti-PD-1 mAb usages are as follows: Nivolumab, 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Sintilimab, 200mg solution intravenously once daily, Q3W.
DRUG	Chemotherapy	CAPOX: Capecitabine 1000 mg/m2 twice a day, days 1-14 and oxaliplatin 130 mg/m2, day 1, every 3 weeks
PROCEDURE	R0 total/subtotal gastrectomy with D2 lymphadenectomy	For resectable participants, gastrectomy with standard D2 lymphadenectomy is commonly used. The type of gastrectomy performed depends on the location and extent of the primary lesion.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2024-12-11
• Last updated: 2025-06-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study