Gastric CarcinomaPhase 3NCT06944496
A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 3 study testing Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine and Tislelizumab+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 Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma. 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+Oxaliplatin+Capecitabine and Tislelizumab+Oxaliplatin+Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 15 May 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, metastatic, or recurrent gastric or gastroesophageal junction adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic gastric cancer
- HER2-low expression
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- At least one assessable lesion according to RECIST v1.1 criteria
- Adequate organ function
- For female subjects: They should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment. A blood pregnancy test must be negative within 7 days before the study medication is administered, and they must not be breastfeeding
- For male subjects: They should be surgically sterilized or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study 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
- Uncontrolled diarrhea
- Bone metastases with a risk of paraplegia
- Past or current interstitial lung disease, or presence of drug-induced pneumonia, radiation pneumonia, or severely impaired lung function
- Other malignancies within 5 years before the first dose, except for those expected to be cured with treatment (e.g., adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)
- 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
Beijing Cancer Hospital
Beijing, BJ-Beijing, 100021
shen lin shen, PhD, 18018029623
About this study
Official title: A Phase III, Randomized Trial Comparing RC48 Plus Chemotherapy and Tislelizumab With Tislelizumab Plus Chemotherapy as First-line Treatment in Participants With HER2 Low Advanced Gastric or Gastrioesophageal Junction Adenocarcinoma (RC48-C039)
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.
- Conditions
- Gastric Carcinoma
- Being tested
- Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine
- 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+Tislelizumab+Oxaliplatin+CapecitabineBiological
Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W; Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 100 mg/m², IV, D1, Q3W; Capecitabine: 750 mg/m², po, BID, D1-D14, Q3W
Tislelizumab+Oxaliplatin+CapecitabineBiological
Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with CAPOX | Active comparator | Not described Receives: Biological: Tislelizumab+Oxaliplatin+Capecitabine |
| Disitamab Vedotin Combined with Tislelizumab and CAPOX | Experimental | Not described Receives: Biological: Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: 24 months
Secondary outcomes (6)
Overall Survival
Measured: up to 5 years
Objective Response Rate
Measured: 24 months
Disease Control Rate
Measured: 24 months
Duration of Response
Measured: 24 months
Patient-Reported Outcomes
Measured: 24 months
Adverse Events
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 posted25 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion15 May 2028 (estimated)
- Study completion15 May 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
- 616 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
- NCT06944496
- Sponsor's protocol ID
- RC48-C039
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized Trial Comparing RC48 Plus Chemotherapy and Tislelizumab With Tislelizumab Plus Chemotherapy as First-line Treatment in Participants With HER2 Low Advanced Gastric or Gastrioesophageal Junction Adenocarcinoma (RC48-C039)
- ClinicalTrials.gov ID
- NCT06944496
- Acronym / sponsor ID
- RC48-C039
- Conditions
- Gastric Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2030 (estimated)
- First posted
- 25 Apr 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.
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with CAPOX | Active comparator | Biological: Tislelizumab+Oxaliplatin+Capecitabine |
| Disitamab Vedotin Combined with Tislelizumab and CAPOX | Experimental | Biological: Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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, metastatic, or recurrent gastric or gastroesophageal junction adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic gastric cancer
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
- Uncontrolled diarrhea
- 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 Vedotin+Tislelizumab+Oxaliplatin+CapecitabineDisitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W; Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 100 mg/m², IV, D1, Q3W; Capecitabine: 750 mg/m², po, BID, D1-D14, Q3W | Biological | Disitamab Vedotin Combined with Tislelizumab and CAPOX |
| Tislelizumab+Oxaliplatin+CapecitabineTislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W | Biological | Tislelizumab combined with CAPOX |
Primary outcome
Progression-Free Survival
Time frame: 24 months
6 secondary outcomes
Overall Survival
Time frame: up to 5 years
Objective Response Rate
Time frame: 24 months
Disease Control Rate
Time frame: 24 months
Duration of Response
Time frame: 24 months
Patient-Reported Outcomes
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 25 Apr 2025.
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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+Oxaliplatin+Capecitabine and Tislelizumab+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 11 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: opening soon, as of the sponsor's last update on 25 Apr 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 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 SU Xiaohong Study Director, M.D (+0810-65391479, xiaohong.su@remegen.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (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 25 Apr 2025.