Gastric AdenocarcinomaPhase 3NCT07584135
JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 3 study testing Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine and Sintilimab& Oxaliplatin Injection& Capecitabine in people with Gastric Adenocarcinoma, run by NingBo Junyan Hongshi Biosciences Co., Ltd at 1 site in China.
Trial summary
This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G/GEJ adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine and Sintilimab& Oxaliplatin Injection& Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2026to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily participated, provided informed consent, signed a written informed consent form, and had good compliance.
- Age ≥18 years (including), male and female. 3)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4）Expected survival period ≥3 months.
- 5）Patients with HER2-negative, unresectable locally advanced, recurrent, or Metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histology/cytology. 6）Previously untreated for systemic therapy for locally advanced, recurrent, or Metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. 7）Positive for CLDN18.2 by IHC testing at the central laboratory. 8）According to the RECIST v1.1 criteria, the patient has ≥1 measurable lesion. 9）The functional level of the organ meets the requirements of the protocol. 10）Agree to use contraception during the study period; females of reproductive potential will undergo a blood pregnancy test within 7 days prior to randomization, with a negative result.
Who cannot join
- Previously received any drug or cell therapy targeting CLDN18.2
- Received major surgery, live vaccine administration, or Drug therapy with other investigational medicinal products, or received radiotherapy within 2 weeks prior to randomization.
- Imaging shows cerebral tumor lesions (unless whole-brain radiotherapy or surgery, etc., local treatment has been completed, and imaging and clinical stability have been assessed according to the protocol) 4)Peripheral neuropathy ≥ Grade 2
- 5）Idiopathic pulmonary fibrosis, Organising pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest computerised tomography (CT) scan 6）Pericardial effusion, Pleural effusion, or ascites with a large volume, or with clinical symptoms, or requiring symptomatic treatment.
- 7）There is a need for systemic antimicrobial or antiviral therapy for active infection.
- 8）Subjects who cannot take oral medications, require enteral nutrition to maintain feeding, or have Malabsorption syndrome or other conditions affecting gastrointestinal Malabsorption.
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- 9）Presence of biliary or gastrointestinal obstruction, or persistent recurrent vomiting 10）Weight loss of >10% within the previous 2 months or severe Malnutrition, known prior to randomization.
- 11）History of gastrointestinal perforation and/or fistula within the prior 6 months; presence of high-risk Haemorrhage of digestive tract disease or risk of rupture bleeding or gastrointestinal/respiratory fistula 12）Serious cardiovascular and cerebrovascular diseases 13）History of systemic treatment for autoimmune diseases within the past 2 years 14）Randomly selected patients with any other Neoplasm malignant within the past 5 years.
- 15）Known severe allergic reaction to any ingredient in the study drug formulation 16）Known active Hepatitis B, active Hepatitis C, human immunodeficiency (HIV) infection, or have undergone allogeneic stem cell or Solid organ transplant.
- 17）Diseases determined by researchers to be unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Junliang Li contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, PhD, 18758246502, xurh@sysucc.org.cn
Ruihua Xu, Ph.D
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label Phase III Clinical Trial Evaluating the Efficacy and Safety of JS107 in Combination With Toripalimab and Chemotherapy Versus Sintilimab in Combination With Chemotherapy as First-line Treatment for CLDN18.2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G/GEJ adenocarcinoma.
The research subjects were patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant/adjuvant therapy that occurred more than 6 months after disease progression/recurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine, Sintilimab& Oxaliplatin Injection& Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection JS107&Toripalimab& Oxaliplatin Injection& CapecitabineDrug
JS107: 2 mg/kg on day 1 Q3W; Toripalimab (T): 240 mg on day 1 Q3W. Capecitabine (C): 750 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 100mg/m² on Day1 Q3W, Maximum of 6 cycles.
Sintilimab& Oxaliplatin Injection& CapecitabineDrug
Sintilimab: 3 mg/kg or 200 mg Day1 Q3W, Capecitabine: 1000 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 130mg/m² on Day1 Q3W, Maximum of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| JS107 in combination with Toripalimab and XELOX Chemotherapy | Experimental | Not described Receives: Drug: Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine |
| Sintilimab in combination with XELOX Chemotherapy | Active comparator | Not described Receives: Drug: Sintilimab& Oxaliplatin Injection& Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
BICR-PFS
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Measured: up to 2 years
Overall Survival
The primary endpoint of overall survival (OS) in this multicenter, randomized, open-label Phase III study is the time from randomization to death from any cause, aiming to compare the benefit between JS107 and investigator's choice of therapy in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy.
Measured: up to 5 years
Secondary outcomes (11)
INV-PFS
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
Measured: up to 2 years
BICR-ORR or INV-ORR
ORR evaluated by investigators or BICR (according to the RECIST v1.1 criteria)
Measured: up to 2 years
BICR-DCR or INV -DCR
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
Measured: up to 2 years
BICR-DoR or INV -DoR
DoR (based on the RECIST v1.1 criteria) evaluated by investigators or BICR
Measured: up to 2 years
The incidence rate and severity of AE
The incidence and severity of adverse events (AEs) evaluated according to the NCI-CTC AE v5.0 standard
Measured: up to 2 years
Valley concentration of JS107
Valley concentration of JS107 (including ADC, total antibody, and toxin)
Measured: up to 2 years
Anti-drug antibodies (ADA) for JS107
Incidence and titer of anti-drug antibodies (ADA) for JS107 (including ADC, total antibody, and toxin)
Measured: up to 2 years
Incidence of neutralizing antibodies (NAb) to JS107
Incidence of neutralizing antibodies (NAb) to JS107 (including ADC, total antibody, and toxin)
Measured: up to 2 years
Blood trough concentration of toripalimab
To evaluate the blood trough concentration of toripalimab
Measured: up to 2 years
Immunogenicity of toripalimab
Incidence and titer of anti-drug antibody (ADA) of toripalimab,
Measured: up to 2 years
Incidence of neutralizing antibodies (NAb) to Toripalimab
ADA-positive samples for the presence of Neutralising antibodies (Nab).
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start28 May 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NingBo Junyan Hongshi Biosciences Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584135
- Sponsor's protocol ID
- JS107-004-III-GC
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-label Phase III Clinical Trial Evaluating the Efficacy and Safety of JS107 in Combination With Toripalimab and Chemotherapy Versus Sintilimab in Combination With Chemotherapy as First-line Treatment for CLDN18.2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07584135
- Acronym / sponsor ID
- JS107-004-III-GC
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- NingBo Junyan Hongshi Biosciences Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 May 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 study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G/GEJ adenocarcinoma.
The research subjects were patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant/adjuvant therapy that occurred more than 6 months after disease progression/recurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS107 in combination with Toripalimab and XELOX Chemotherapy | Experimental | Drug: Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine |
| Sintilimab in combination with XELOX Chemotherapy | Active comparator | Drug: Sintilimab& Oxaliplatin Injection& Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient voluntarily participated, provided informed consent, signed a written informed consent form, and had good compliance.
- Age ≥18 years (including), male and female. 3)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4）Expected survival period ≥3 months.
- 5）Patients with HER2-negative, unresectable locally advanced, recurrent, or Metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histology/cytology. 6）Previously untreated for systemic therapy for locally advanced, recurrent, or Metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. 7）Positive for CLDN18.2 by IHC testing at the central laboratory. 8）According to the RECIST v1.1 criteria, the patient has ≥1 measurable lesion. 9）The functional level of the organ meets the requirements of the protocol. 10）Agree to use contraception during the study period; females of reproductive potential will undergo a blood pregnancy test within 7 days prior to randomization, with a negative result.
Key exclusion criteria (10 listed)
- Previously received any drug or cell therapy targeting CLDN18.2
- Received major surgery, live vaccine administration, or Drug therapy with other investigational medicinal products, or received radiotherapy within 2 weeks prior to randomization.
- Imaging shows cerebral tumor lesions (unless whole-brain radiotherapy or surgery, etc., local treatment has been completed, and imaging and clinical stability have been assessed according to the protocol) 4)Peripheral neuropathy ≥ Grade 2
- 5）Idiopathic pulmonary fibrosis, Organising pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest computerised tomography (CT) scan 6）Pericardial effusion, Pleural effusion, or ascites with a large volume, or with clinical symptoms, or requiring symptomatic treatment.
- 7）There is a need for systemic antimicrobial or antiviral therapy for active infection.
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 |
|---|---|---|
| Injection JS107&Toripalimab& Oxaliplatin Injection& CapecitabineJS107: 2 mg/kg on day 1 Q3W; Toripalimab (T): 240 mg on day 1 Q3W. Capecitabine (C): 750 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 100mg/m² on Day1 Q3W, Maximum of 6 cycles. | Drug | JS107 in combination with Toripalimab and XELOX Chemotherapy |
| Sintilimab& Oxaliplatin Injection& CapecitabineSintilimab: 3 mg/kg or 200 mg Day1 Q3W, Capecitabine: 1000 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 130mg/m² on Day1 Q3W, Maximum of 6 cycles. | Drug | Sintilimab in combination with XELOX Chemotherapy |
Primary outcome
BICR-PFS
Time frame: up to 2 years
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Overall Survival
Time frame: up to 5 years
The primary endpoint of overall survival (OS) in this multicenter, randomized, open-label Phase III study is the time from randomization to death from any cause, aiming to compare the benefit between JS107 and investigator's choice of therapy in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy.
11 secondary outcomes
INV-PFS
Time frame: up to 2 years
BICR-ORR or INV-ORR
Time frame: up to 2 years
BICR-DCR or INV -DCR
Time frame: up to 2 years
BICR-DoR or INV -DoR
Time frame: up to 2 years
The incidence rate and severity of AE
Time frame: up to 2 years
Valley concentration of JS107
Time frame: up to 2 years
Anti-drug antibodies (ADA) for JS107
Time frame: up to 2 years
Incidence of neutralizing antibodies (NAb) to JS107
Time frame: up to 2 years
Blood trough concentration of toripalimab
Time frame: up to 2 years
Immunogenicity of toripalimab
Time frame: up to 2 years
Incidence of neutralizing antibodies (NAb) to Toripalimab
Time frame: up to 2 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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Junliang Li contact
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 Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine and Sintilimab& Oxaliplatin Injection& Capecitabine in people with Gastric Adenocarcinoma, run by NingBo Junyan Hongshi Biosciences 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 3 inclusion and 10 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 29 Jun 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 Bifeng Liu (021-61058800, bifeng_liu@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BICR-PFS (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 29 Jun 2026.