Gastric CarcinomaPhase 3NCT07315750
A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
A Phase 3 study testing Disitamab Vedotin, Tislelizumab and CAPOX (oxaliplatin/capecitabine) in people with Gastric Carcinoma, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- Disitamab Vedotin, Tislelizumab and CAPOX (oxaliplatin/capecitabine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2026to 31 Dec 2030
- Phase
- Phase 3
- 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
- Voluntarily consent to participate in the study and sign the informed consent form
- Expected survival period >12 weeks
- ECOG Performance Status 0 or 1
- Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy
- HER2-high expression
Show all 10Show fewer
- At least one assessable lesion according to RECIST v1.1 criteria
- Adequate organ function
- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.
- Able to understand the study requirements and willing to comply with the study and follow-up procedures
Who cannot join
- Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
- Peripheral neuropathy > Grade 1
- Tumor lesions with a tendency to bleed
- Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption
- Bone metastases with a risk of paraplegia
- Past or current interstitial lung disease, or severely impaired lung function
- Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment
- Pregnant or breastfeeding women
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
Beijing Cancer Hospital
Beijing, BJ-Beijing, 100021
Lin shen, 86+010-88196561, doctorshenlin@sina.cn
About this study
Official title: A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.
- Conditions
- Gastric Carcinoma
- Being tested
- Disitamab Vedotin, Tislelizumab, CAPOX (oxaliplatin/capecitabine), Trastuzumab, Pembrolizumab
- 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 VedotinDrug
Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W;
TislelizumabDrug
Tislelizumab: 200 mg, IV, D1, Q3W
CAPOX (oxaliplatin/capecitabine)Drug
Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W;
TrastuzumabDrug
Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W;
PembrolizumabDrug
Pembrolizumab: 200mg, IV, D1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin Combined with Trastuzumab and Tislelizumab | Experimental | Participants will receive Disitamab Vedotin, Trastuzumab and Tislelizumab until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first). Receives: Drug: Disitamab Vedotin; Drug: Tislelizumab; Drug: Trastuzumab |
| Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab | Active comparator | Participants will receive CAPOX, Trastuzumab and Trastuzumab. Only subjects whose PD-L1 expression is confirmed as CPS ≥1 by the central laboratory will receive pembrolizumab. Treatment will continue until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first). Receives: Drug: CAPOX (oxaliplatin/capecitabine); Drug: Trastuzumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (assessed by the BIRC)
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 as assessed by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first.
Measured: 24 months
Secondary outcomes (9)
Overall Survival
Overall survival (OS) refers to the time from the date of randomization to the date of death from any cause.
Measured: up to 5 years
Progression-Free Survival (assessed by the investigator)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigators or death due to any cause, whichever occurs first.
Measured: 24 months
Objective Response Rate (assessed by the BIRC and investigators)
ORR is defined as the percentage of subjects who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 as assessed by BICR and investigators .
Measured: 24 months
Disease Control Rate (assessed by the BIRC and investigators)
DCR is defined as the proportion of subjects whose BOR is rated as CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR/ investigators .
Measured: 24 months
Duration of Response (assessed by the BIRC and investigators)
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first.
Measured: 24 months
Patient-Reported Outcomes (EORTC-QLQ-C30)
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state.
Measured: 24 months
Patient-Reported Outcomes (EORTCQLQ-STO22)
Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) STO22. It will be evaluated at Screening and Tumor Assessment Visit. The higher score means the worse quality of life.
Measured: 24 months
Patient-Reported Outcomes (EQ-5D-5L)
EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Measured: 24 months
Adverse Events
Incidence, severity, and relationship to the investigational product of adverse events (AEs) and serious adverse events (SAEs)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start12 Jan 2026
- Primary completion30 Jun 2029 (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 Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 555 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315750
- Sponsor's protocol ID
- RC48-C040
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2025
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression
- ClinicalTrials.gov ID
- NCT07315750
- Acronym / sponsor ID
- RC48-C040
- Conditions
- Gastric Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 555 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Jan 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.
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin Combined with Trastuzumab and Tislelizumab | Experimental | Drug: Disitamab Vedotin, Drug: Tislelizumab, Drug: TrastuzumabParticipants will receive Disitamab Vedotin, Trastuzumab and Tislelizumab until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first). |
| Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab | Active comparator | Drug: CAPOX (oxaliplatin/capecitabine), Drug: Trastuzumab, Drug: PembrolizumabParticipants will receive CAPOX, Trastuzumab and Trastuzumab. Only subjects whose PD-L1 expression is confirmed as CPS ≥1 by the central laboratory will receive pembrolizumab. Treatment will continue until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily consent to participate in the study and sign the informed consent form
- Expected survival period >12 weeks
- ECOG Performance Status 0 or 1
- Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy
Key exclusion criteria (8 listed)
- Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
- Peripheral neuropathy > Grade 1
- Tumor lesions with a tendency to bleed
- Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption
- Bone metastases with a risk of paraplegia
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 VedotinDisitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W; | Drug | Disitamab Vedotin Combined with Trastuzumab and Tislelizumab |
| TislelizumabTislelizumab: 200 mg, IV, D1, Q3W | Drug | Disitamab Vedotin Combined with Trastuzumab and Tislelizumab |
| CAPOX (oxaliplatin/capecitabine)Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W; | Drug | Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab |
| TrastuzumabTrastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W; | Drug | Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab, Disitamab Vedotin Combined with Trastuzumab and Tislelizumab |
| PembrolizumabPembrolizumab: 200mg, IV, D1, Q3W | Drug | Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab |
Primary outcome
Progression-Free Survival (assessed by the BIRC)
Time frame: 24 months
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 as assessed by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first.
9 secondary outcomes
Overall Survival
Time frame: up to 5 years
Progression-Free Survival (assessed by the investigator)
Time frame: 24 months
Objective Response Rate (assessed by the BIRC and investigators)
Time frame: 24 months
Disease Control Rate (assessed by the BIRC and investigators)
Time frame: 24 months
Duration of Response (assessed by the BIRC and investigators)
Time frame: 24 months
Patient-Reported Outcomes (EORTC-QLQ-C30)
Time frame: 24 months
Patient-Reported Outcomes (EORTCQLQ-STO22)
Time frame: 24 months
Patient-Reported Outcomes (EQ-5D-5L)
Time frame: 24 months
Adverse Events
Time frame: 24 months
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 22 Sep 2026.
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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 3 study testing Disitamab Vedotin, Tislelizumab and CAPOX (oxaliplatin/capecitabine) in people with Gastric Carcinoma, run by RemeGen Co., Ltd. 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 10 inclusion and 8 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 22 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hongfang Li (86+010-65018841, hongfang.li@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (assessed by the BIRC) (time frame: 24 months). 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 22 Sep 2026.