GC/GEJCPhase 2NCT07474324
Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial
A Phase 2 study testing RC48, SOX Chemotherapy and SOX(normal) in people with GC/GEJC, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GC/GEJC
- What is being tested?
- RC48, SOX Chemotherapy and SOX(normal)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+).
Show all 12Show fewer
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Hao Xu, 13851530117, hxu@njmu.edu.cn
About this study
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.
Read the 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.
- Conditions
- GC/GEJC
- Being tested
- RC48, SOX Chemotherapy, SOX(normal)
- Keywords
- adjuvant therapy, Gastric Adenocarcinom, RC48, SOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48Drug
RC48 2.5mg/kg iv. ,q3w
SOX ChemotherapyDrug
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.
SOX(normal)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| RC48+SOX | Experimental | Patients will first receive 6 to 8 cycles of treatment with RC48 + SOX Receives: Drug: RC48; Drug: SOX Chemotherapy |
| SOX | Active comparator | Patients will receive 6 to 8 cycles of treatment with SOX Receives: Drug: SOX(normal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year-DFS rate
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.
Measured: 3 years
Secondary outcomes (5)
Disease-Free Survival (DFS)
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.
Measured: 3 years
2-year-OS rate
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.
Measured: 2 years
3-year OS rate
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.
Measured: 3 years
Overall Survival (OS)
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.
Measured: 5 years
Incidence rate of adverse events (AEs)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GC/GEJCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474324
- Sponsor's protocol ID
- RCVDTYPEC174
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial
- ClinicalTrials.gov ID
- NCT07474324
- Acronym / sponsor ID
- RCVDTYPEC174
- Conditions
- GC/GEJC
- Keywords
- adjuvant therapy, Gastric Adenocarcinom, RC48, SOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC48+SOX | Experimental | Drug: RC48, Drug: SOX ChemotherapyPatients will first receive 6 to 8 cycles of treatment with RC48 + SOX |
| SOX | Active comparator | Drug: SOX(normal)Patients will receive 6 to 8 cycles of treatment with SOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC48RC48 2.5mg/kg iv. ,q3w | Drug | RC48+SOX |
| SOX ChemotherapyS-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. | Drug | RC48+SOX |
| SOX(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. | Drug | SOX |
Primary outcome
3-year-DFS rate
Time frame: 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.
5 secondary outcomes
Disease-Free Survival (DFS)
Time frame: 3 years
2-year-OS rate
Time frame: 2 years
3-year OS rate
Time frame: 3 years
Overall Survival (OS)
Time frame: 5 years
Incidence rate of adverse events (AEs)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
Related trials for GC/GEJC
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
RecruitingPhase 3
A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingPhase 2
Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 1/2
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
Advanced Solid Tumor
Not yet recruitingPhase 2
Trastuzumab Combined With Retlirafusp Alfa in Treating HER2（Human Epidermal Growth Factor Receptor 2） 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure
GC, GEJC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RC48, SOX Chemotherapy and SOX(normal) in people with GC/GEJC, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year-DFS rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.