Drug Pipeline
PHASE2
● Phase II
Phase II Trial Explores Serplulimab and Chemoradiotherapy for GEJ Adenocarcinoma
ClinicalTrials.gov
Published March 28, 2026
The First Affiliated Hospital with Nanjing Medical University
NCT07277439 ↗
This phase II, single-center, randomized controlled trial is currently recruiting 48 patients with resectable, locally advanced gastroesophageal junction adenocarcinoma. The trial is designed to evaluate the efficacy of neoadjuvant therapies involving serplulimab, a PD-1 inhibitor, combined with modified SOX (mSOX) chemotherapy and radiotherapy. Patients are randomized in a 1:2 ratio into two groups. Arm A (n=16) receives radiochemoimmunotherapy with serplulimab, oxaliplatin, S-1, and radiotherapy. Arm B (n=32) receives the same regimen plus 9 weeks of neoadjuvant thymosin. The primary endpoint is the complete pathological response (pCR) rate, defined as the absence of residual tumor cells and negative lymph nodes upon microscopic examination. Safety assessments are conducted after each therapy cycle and 30 days postoperatively. Follow-up occurs every 3 months for the first year and every 6 months for up to 2 years postoperatively. The trial is sponsored by The First Affiliated Hospital with Nanjing Medical University and is expected to start on December 16, 2025, with primary completion by February 16, 2027.
AI Accuracy Review: 9/10
· Auto-published
Imagine facing a diagnosis of advanced stomach cancer and wondering about your treatment options. A new clinical trial is exploring a promising approach that combines immunotherapy and chemotherapy before surgery for patients with resectable gastroesophageal junction adenocarcinoma. This trial aims to enroll 48 patients who have not received any prior treatment. Participants will be randomly assigned to two groups: one receiving a combination of therapies, including serplulimab, modified SOX chemotherapy, and radiotherapy, while the other group will also receive thymosin. The main goal is to see if this treatment can lead to a complete pathological response, meaning no surviving cancer cells are found after treatment. Safety assessments will be conducted throughout the trial, with follow-ups scheduled for up to two years after surgery. This research could potentially change the way advanced stomach cancer is treated, offering new hope for patients and their families.
What this means for you: This trial could redefine treatment for advanced stomach cancer, aiming for no remaining cancer cells after therapy.
View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): Gastric Cancer
Intervention(s): Radiochemoimmunotherapy (OTHER), Immunomodulation (OTHER)
This is a prospective, single-center, randomized controlled, phase II clinical trial. The study aims to enroll 48 patients with resectable, locally advanced gastroesophageal junction adenocarcinoma who have not received any treatment. After obtaining informed consent and meeting the inclusion/exclusion criteria, patients were randomly assigned preoperatively in a 1:2 ratio:
Arm A. Radiochemoimmunotherapy group (n=16): 3 cycles of serplulimab combined with modified SOX (mSOX) combined with radiotherapy, as details:
Cycle 1:
Serplulimab: 300 mg, i.v., D1 Oxaliplatin: 130 mg/m², i.v., D1 S-1 (Tegafur/Gimeracil/Oteracil): Oral administration: 40 mg twice daily for BSA \< 1.25 m²; 50 mg twice daily for BSA 1.25 to \<1.5 m²; 60 mg twice daily for BSA ≥ 1.5 m². Administered from D1 to D14, followed by a rest period from D15 to D21.
This cycle lasts 21 days.
Cycle 2:
Serplulimab: 300 mg, i.v., D1 S-1: Oral administration: 40 mg twice daily from D1 to D14 of the treatment cycle.
Radiotherapy: Commences between D2 and D5 after the start of Cycle 2. The clinical target volume (CTV) is defined as the endoscopically marked tumor boundary and adjacent metastatic lymph nodes plus a 5-10 mm margin. The planning target volume (PTV) is generated by adding an additional 5-10 mm margin to the CTV. The planned dose to the PTV is 44 Gy administered in 22 fractions, with 5 fractions per week. This is followed by a 7-day rest interval.
This cycle lasts 33 days.
Cycle 3:
Serplulimab: 300 mg, i.v., D1 Oxaliplatin: 130 mg/m², i.v., D1 Fluorouracil Injection: Administered as a 400 mg/m² intravenous bolus on day 1, followed immediately by a continuous intravenous infusion of 2400-3000 mg/m² over 46 hours.
This is followed by a 7-day rest period. This cycle lasts 9 days.
Arm B: Immunomodulation group (n=32): 3 cycles of serplulimab combined with mSOX combined with radiotherapy (as described above) and 9 weeks of neoadjuvant thymosin;
After neoadjuvant therapy, the efficacy of the therapy and the feasibility of radical D2 resection are assessed through imaging examinations. Efficacy evaluation is performed within 2 weeks of the completion of neoadjuvant therapy, and radical gastrectomy is performed within 4-6 weeks. Postoperative treatment is determined jointly by the clinician and the patient based on actual clinical practice.
The primary endpoint is complete pathological response (pCR) rate, defined as the proportion of subjects who have no residual surviving tumor cells under microscopic examination and are negative for lymph nodes.
Safety assessment: Safety assessments are performed after each cycle of neoadjuvant therapy and 30 days postoperatively.
Event follow-up: Follow-up events are then conducted every 3 months for the first year postoperatively, and every 6 months for 1-2 years, up to 2 years postoperatively.
Primary Outcome(s): Complete pathological response (pCR) rate
Enrollment: 48 (ESTIMATED)
Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
Start: 2025-12-16 | Primary Completion: 2027-02-16
