GC/GEJC
Conditions
Keywords
adjuvant therapy, Gastric Adenocarcinom, RC48, SOX
Brief summary
This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate/high-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.
Detailed description
After providing informed consent and meeting all eligibility criteria, participants will begin adjuvant therapy with disitamab vedotin plus chemotherapy (SOX) approximately four weeks after surgery, continuing for 6-8 cycles. Post-operative imaging assessments will be performed every three months until disease recurrence. Following recurrence, survival follow-up will be conducted every three months. Safety visits will continue from first drug administration until 60 days after the last dose or until initiation of new anti-tumor therapy.
Interventions
DRUGRC48
RC48 2.5mg/kg iv. ,q3w
DRUGSOX Chemotherapy
S-1: 40-60 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 100 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.
DRUGSOX(normal)
S-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 75 years. * Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status. * No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery. * Histopathologically confirmed gastric adenocarcinoma. * Pathological stage III gastric and gastroesophageal junction adenocarcinoma patients (according to the 8th edition of the American Joint Committee on Cancer \[AJCC\] staging system). * HER2 moderate-to-high expression (IHC 3+ or 2+). * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. * Expected survival time ≥ 3 months. * Able to understand the study protocol, voluntarily participate in the study, and provide written informed consent; * Good compliance and able to cooperate with the treatment regimen specified in this study; * Possesses complete imaging and pathological clinical data; * Adequate organ and bone-marrow function.
Exclusion criteria
* Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed; * Unable to receive disitamab vedotin or SOX chemotherapy; * Unable to comply with the required follow-up schedule; * Unable to accept the treatment regimen specified in this protocol; * Unable or unwilling to undergo mandated response assessments (e.g., CT imaging); * Active autoimmune disease; * History of psychoactive-substance abuse that cannot be discontinued, or any severe/uncontrolled psychiatric disorder, or any severe/uncontrolled systemic disease; * Any concomitant condition that, in the investigator's opinion, poses significant risk to the subject or could compromise study completion; * Other malignancies within 5 years before screening, except adequately treated cancers considered cured (e.g., thyroid cancer, cervical carcinoma in situ, basal/squamous-cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery); * Lactating women; * Prior neoadjuvant therapy or intra-operative intraperitoneal chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year-DFS rate | 3 years | The 3-year disease-free survival (DFS) rate is defined as the proportion of participants who remain free of any of the following events for at least three years from the date of randomization: tumor recurrence, new primary tumor, or death from any cause. Patients who undergo curative-intent surgery and experience none of these events are considered disease-free. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) | 3 years | Defined from the date of completion of curative-intent treatment (e.g., surgery, adjuvant chemotherapy) to the date of first documentation of disease recurrence (e.g., tumor relapse, metastasis) or death from any cause, whichever occurs first. |
| 2-year-OS rate | 2 years | The 2-year overall survival (OS) rate is defined as the proportion of participants who remain alive for at least two years from the date of randomization, regardless of whether disease recurrence or progression has occurred. |
| 3-year OS rate | 3 years | The 3-year overall survival (OS) rate is defined as the proportion of participants who remain alive for at least two years from the date of randomization, regardless of whether disease recurrence or progression has occurred. |
| Overall Survival (OS) | 5 years | Defined from date of recruit to date of first documentation of death from any cause or censored at the date of the last follow-up. |
| Incidence rate of adverse events (AEs) | 3 years | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 |
Countries
China
Outcome results
None listed