Gastric CancerPhase 2RemissionNCT07194005
Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer
A Phase 2 study testing Disitamab vedotin(RC48), Sintilimab and S-1 in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastric cancer exhibiting HER2 IHC 1+/2+ expression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Disitamab vedotin(RC48), Sintilimab and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 30 Sep 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily enrolled and provided written informed consent;
- Aged 18-70 years (inclusive), male or female;
- Histologically and/or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
- No prior systemic anticancer therapy;
- HER2 immunohistochemistry (IHC) result of 2+ or 1+, based on either previous test results (confirmed by the investigator) or central laboratory assessment;
- Presence of a single initial unresectable factor;
Show all 23Show fewer
- At least one measurable lesion per RECIST 1.1;
- Life expectancy ≥ 6 months;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ function, defined as follows:
- Hematological (within 14 days prior to screening, without transfusion or granulocyte colony-stimulating factor [G-CSF] support):
- Hemoglobin ≥ 90 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
- White blood cell count ≥ 3.0 × 10⁹/L;
- Platelet count ≥ 80 × 10⁹/L;
- Biochemical (within 14 days prior to screening, without albumin infusion):
- Albumin ≥ 28 g/L;
- Total bilirubin ≤ 2 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN in the absence of liver metastases; or ≤ 5 × ULN if liver metastases are present;
- Serum creatinine ≤ 1.5 × ULN; or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault formula;
- Coagulation:
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN;
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Who cannot join
- History of malignancies other than gastric cancer, with the following exceptions:
- Malignancies treated with curative intent and with no evidence of disease for 5 years;
- Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or other in situ carcinomas.
- Conditions affecting the absorption, distribution, metabolism, or excretion of the investigational drug(s) (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.).
- Previous allogeneic stem cell or solid organ transplantation.
- Prior systemic antitumor therapy (including Chinese herbal medicine with antitumor indications) completed less than 4 weeks before the first dose of study treatment, or with prior treatment-related adverse events not recovered to ≤ CTCAE grade 1 (except for alopecia or pigmentation).
Show all 18Show fewer
- History or presence of congenital or acquired immunodeficiency disorders.
- Active or previously documented autoimmune or inflammatory disorders (including but not limited to autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism, hypothyroidism, asthma requiring bronchodilators, etc.). Patients with vitiligo, childhood asthma that has fully resolved without intervention in adulthood, or other conditions deemed eligible by the investigator may be included.
- Use of systemic immunosuppressive therapy within 2 weeks prior to enrollment, or anticipated need for such therapy during the study, with the following exceptions:
- Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular);
- Systemic corticosteroids at a dose ≤ 10 mg/day prednisone or equivalent;
- Prophylactic corticosteroids for hypersensitivity reactions.
- Known or suspected history of hypersensitivity to disitamab vedotin, anti-PD-1 agents, chimeric or humanized antibodies or fusion proteins, or any excipient of the investigational drug(s).
- History of thrombotic or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.
- Patients assessed by the physician to be at significant risk of bleeding, including but not limited to:
- Major bleeding (>30 mL within 3 months) or hemoptysis (>5 mL within 4 weeks); endoscopic evaluation may be performed to confirm eligibility;
- Active bleeding or coagulation disorders;
- Bleeding tendency or current use of thrombolytic, anticoagulant, or antiplatelet therapy.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200230
Xiaowen Liu, 18017317145, liuxw1129@hotmail.com
About this study
Official title: Efficacy and Safety of RC48 (Disitamab Vedotin) Combined With Sintilimab and SOX for HER2 IHC 1+/2+ Unresectable Locally Advanced or Advanced Gastric Cancer Conversion Therapy
This study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastric cancer exhibiting HER2 IHC 1+/2+ expression. The trial plans to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ status. Participants will receive disitamab vedotin combined with sintilimab and SOX for 4 to 6 treatment cycles. Those who achieve successful conversion will undergo surgical resection, while patients with unsuccessful conversion will either continue the original regimen or switch to an alternative treatment at the investigator's discretion.
Read the detailed description
This is an open-label, single-arm, exploratory study designed to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ locally advanced or metastatic gastric cancer. The primary objective is to assess the efficacy of the combination regimen based on the R0 resection rate. Tumor response will be evaluated every 6 to 12 weeks via imaging to determine whether surgical criteria are met. Patients who meet the criteria for operability will proceed to surgery, and postoperative adjuvant therapy will be tailored by the investigator based on individual patient conditions. For those who do not achieve successful conversion, the investigator will decide whether to continue the original treatment or transition to an alternative therapeutic strategy.
- Conditions
- Gastric Cancer
- Being tested
- Disitamab vedotin(RC48), Sintilimab, S-1, Oxaliplatin
- Keywords
- gastric cancer, disitamab vedotin, conversion therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab vedotin(RC48)Drug
Also called RC48
2.5 mg/kg, administered intravenously every 3 weeks (Q3W) on Day 1 of each cycle.
SintilimabDrug
200 mg, administered intravenously, d1, every 3 weeks.
S-1Drug
Also called Tegafur Gimeracil Oteracil Potassium Capsule
Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks.
OxaliplatinDrug
130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conversion therapy | Experimental | Drug: Disitamab Vedotin in combination with sintilimab and SOX Receives: Drug: Disitamab vedotin(RC48); Drug: Sintilimab; Drug: S-1; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Defined as no residue under the microscope after resection
Measured: Within 1 month of surgery
Secondary outcomes (5)
Pathologic complete response
The number of people who have achieved complete pathological remission accounted for the proportion of people who met the plan.
Measured: Within 1 month of surgery.
Overall survival
The time from the start of system therapy to the death of any cause.
Measured: 2 years from the start of system therapy.
1/2-year survival rate
Percentage of subjects who are alive without death event at 1/2 years.
Measured: 1/2 years from the start of system therapy.
Adverse events(all grades）
Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0
Measured: From the start of system therapy to 6 months after surgery.
Serious adverse events(≥grade 3）
Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0
Measured: From the start of system therapy to 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start4 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Not applicable
- Intervention model
- Single group
- Model description
- Disitamab vedotin in combination with sintilimab and SOX as conversion therapy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenglin Liu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194005
- Sponsor's protocol ID
- RCVDTYPEC092
- Acronym
- Remission
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data is protected.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of RC48 (Disitamab Vedotin) Combined With Sintilimab and SOX for HER2 IHC 1+/2+ Unresectable Locally Advanced or Advanced Gastric Cancer Conversion Therapy
- ClinicalTrials.gov ID
- NCT07194005
- Acronym / sponsor ID
- Remission / RCVDTYPEC092
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, disitamab vedotin, conversion therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 26 Sep 2025 (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 study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastric cancer exhibiting HER2 IHC 1+/2+ expression. The trial plans to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ status. Participants will receive disitamab vedotin combined with sintilimab and SOX for 4 to 6 treatment cycles. Those who achieve successful conversion will undergo surgical resection, while patients with unsuccessful conversion will either continue the original regimen or switch to an alternative treatment at the investigator's discretion.
Detailed description
This is an open-label, single-arm, exploratory study designed to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ locally advanced or metastatic gastric cancer. The primary objective is to assess the efficacy of the combination regimen based on the R0 resection rate. Tumor response will be evaluated every 6 to 12 weeks via imaging to determine whether surgical criteria are met. Patients who meet the criteria for operability will proceed to surgery, and postoperative adjuvant therapy will be tailored by the investigator based on individual patient conditions. For those who do not achieve successful conversion, the investigator will decide whether to continue the original treatment or transition to an alternative therapeutic strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Disitamab vedotin in combination with sintilimab and SOX as conversion therapy
| Arm | Type | Receives |
|---|---|---|
| Conversion therapy | Experimental | Drug: Disitamab vedotin(RC48), Drug: Sintilimab, Drug: S-1, Drug: OxaliplatinDrug: Disitamab Vedotin in combination with sintilimab and SOX |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Voluntarily enrolled and provided written informed consent;
- Aged 18-70 years (inclusive), male or female;
- Histologically and/or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
- No prior systemic anticancer therapy;
- HER2 immunohistochemistry (IHC) result of 2+ or 1+, based on either previous test results (confirmed by the investigator) or central laboratory assessment;
Key exclusion criteria (18 listed)
- History of malignancies other than gastric cancer, with the following exceptions:
- Conditions affecting the absorption, distribution, metabolism, or excretion of the investigational drug(s) (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.).
- Previous allogeneic stem cell or solid organ transplantation.
- Prior systemic antitumor therapy (including Chinese herbal medicine with antitumor indications) completed less than 4 weeks before the first dose of study treatment, or with prior treatment-related adverse events not recovered to ≤ CTCAE grade 1 (except for alopecia or pigmentation).
- History or presence of congenital or acquired immunodeficiency disorders.
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 |
|---|---|---|
| Disitamab vedotin(RC48)Also: RC482.5 mg/kg, administered intravenously every 3 weeks (Q3W) on Day 1 of each cycle. | Drug | Conversion therapy |
| Sintilimab200 mg, administered intravenously, d1, every 3 weeks. | Drug | Conversion therapy |
| S-1Also: Tegafur Gimeracil Oteracil Potassium CapsuleOral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks. | Drug | Conversion therapy |
| Oxaliplatin130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks. | Drug | Conversion therapy |
Primary outcome
R0 resection rate
Time frame: Within 1 month of surgery
Defined as no residue under the microscope after resection
5 secondary outcomes
Pathologic complete response
Time frame: Within 1 month of surgery.
Overall survival
Time frame: 2 years from the start of system therapy.
1/2-year survival rate
Time frame: 1/2 years from the start of system therapy.
Adverse events(all grades）
Time frame: From the start of system therapy to 6 months after surgery.
Serious adverse events(≥grade 3）
Time frame: From the start of system therapy to 6 months after surgery.
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 26 Sep 2025.
- Individual participant dataSharing planned: No. Individual Participant Data is protected.
Related trials for Gastric Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
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 Disitamab vedotin(RC48), Sintilimab and S-1 in people with Gastric Cancer, run by Fudan 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 23 inclusion and 18 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 26 Sep 2025. 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?
Contact Xiaowen Liu (18017317145, liuxw1129@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: Within 1 month of surgery). 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 26 Sep 2025.