Health TrialsbyHealthPanel

Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

ConditionLocally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Provincial Hospital

About this trial

To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily participated in the study and signed informed consent with good compliance and follow-up;

Adenocarcinoma of the gastric/gastroesophageal junction confirmed by endoscopic pathology (tumor located in the lesser bend of the stomach other than pylorus or the gastroesophageal junction) (Note: Pathology in other hospitals must be consulted by our hospital);

Patients with cT4N+M0 AJCC stage 8 combined with endoscopic, CT, MRI, or PETCT findings;

Age ≥18 years, ≤75 years, male and female;

Disqualifiers

a history of surgery for gastric/esophagogastric junction tumors;

Previous history of fistula caused by primary tumor invasion;

Higher risk of gastrointestinal bleeding and perforation;

Poor nutritional status, BMI less than 18.5kg/m2, or PG-SGA score ≥9;

Trial design

Design model

Single group

Treatments tested in this trial

  • Neoadjuvant Therapy(5×3Gy radiotherapy)

    Radiation

    Radiotherapy: 5×3Gy. The preoperative radiotherapy target was outlined by radiotherapy physicians according to the NCCN Guidelines for Gastric/esophagogastric Junction Tumor 2024 edition and the surgeon's opinions. The first and third cycles were 5×3Gy.

  • Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)

    Drug

    The first and third cycles are 5×3Gy radiotherapy D1 to 5, intravenous administration for tirelizumab 200 mg D6, intravenous administration for oxaliplatin 130 mg/m2 D6, and oral administration twice a day for S-1 40 mg/m2 D6 to 19. The second and fourth cycles are intravenous administration for tirelizumab 200 mg D1, intravenous administration for oxaliplatin 130 mg/m2 D1, and oral administration twice a day for S-1 40 mg/m2 D1 to 14. Every treatment cycle is spaced 1 week apart.

  • Surgical treatment

    Procedure/Surgery

    Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.

  • Adjuvant therapy(SOX chemotherapy)

    Drug

    Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response rate (pCR)

Pathological complete response was defined as pT0N0M0

Time frame
From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.

Secondary outcomes

1

Major pathological response rate (MPR)

The percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy was ≤10%.

Time frame
From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
2

Objective response rate (ORR)

Proportion of patients who achieved a complete response (CR) or a partial response (PR) as assessed by RECIST 1.1.

Time frame
From date of neoadjuvant therapy until the date of surgery, assessed up to 15-17 weeks.
3

R0 resection rate

The proportion of patients who completed R0 resection in the total enrolled patients.

Time frame
From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
4

Treatment safety

CTCAE 5.0 was used to record grade 3 and above treatment-related adverse reactions from the beginning of neoadjuvant therapy to 30 days after the end of surgery.

Time frame
From date of neoadjuvant therapy until the date of 30 days post-surgery, assessed up to 19-21 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now