Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NICT-IORTNCT07870798

Efficacy and Safety of Intraoperative Radiotherapy Combined With Serplulimab Plus Chemotherapy Versus Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Serplulimab, Intraoperative exploration plus intraoperative radiotherapy and Intraoperative exploration without intraoperative radiotherapy in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

This study evaluates the clinical efficacy and safety benefits of neoadjuvant intraoperative radiotherapy combined with immunotherapy and chemotherapy by comparing intraoperative radiotherapy plus serplulimab plus chemotherapy versus serplulimab plus chemotherapy as neoadjuvant therapy in patients with surgically… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric or Gastroesophageal Junction Adenocarcinoma
What is being tested?: Serplulimab, Intraoperative exploration plus intraoperative radiotherapy and Intraoperative exploration without intraoperative radiotherapy
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: No sites listed yet
Study dates: 15 Oct 2026to 31 Dec 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged 18-75 years with gastric or gastroesophageal junction adenocarcinoma, male or female;
According to the AJCC 8th edition gastric cancer staging, patients assessed by abdominal CT as cStage III (cT3-4aN1-3M0), and diagnosed with gastric or gastroesophageal junction adenocarcinoma by gastroscopy and pathology; for gastroesophageal junction (GEJ) cancer, only Siewert type III and Siewert type II subjects who do not require combined thoracotomy are allowed to be enrolled.
Before enrollment, after joint assessment by a attending gastrointestinal surgeon and an imaging technician, the tumor is determined to be cStage III and the patient is eligible for curative-intent R0 resection; the patient agrees to undergo radical surgery and is judged by the surgeon to have no surgical contraindications;
No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy/immunotherapy, etc.;
Expected survival ≥6 months;
Measurable tumor lesions according to RECIST v1.1 criteria (see Appendix 1);

Show all 25Show fewer

ECOG PS score (see Appendix 2) of 0-1 within 7 days before the first dose;
Good cardiac function and suitable for curative-intent resection. If clinically indicated, patients with underlying ischemic, valvular heart disease, or other severe heart disease should undergo preoperative evaluation by a cardiologist;
Normal function of major organs; subjects must meet the following laboratory criteria:
Absolute neutrophil count (ANC) ≥1.5×10⁹/L without the use of granulocyte colony-stimulating factor within the past 14 days;
Platelet count ≥100×10⁹/L without blood transfusion within the past 14 days;
Total bilirubin ≤1.5× upper limit of normal (ULN); if total bilirubin >1.5×ULN but direct bilirubin ≤ULN, enrollment is also permitted;
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;
Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 mL/min;
Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled;
Myocardial enzyme spectrum within the normal range (if the investigator comprehensively judges it as a clinically insignificant isolated laboratory abnormality, enrollment is also permitted); Thyroid function indicators: thyroid-stimulating hormone (TSH), free thyroxine (FT3/FT4) within the normal range or with mild and clinically insignificant abnormalities; Body weight above 40 kg (including 40 kg), or BMI >18.5;
Female patients must meet:
Postmenopausal status (defined as no menstruation for at least 1 year, with no other confirmed cause other than menopause), or have undergone surgical sterilization (oophorectomy and/or hysterectomy), or patients of childbearing potential must simultaneously meet the following requirements:
Pregnancy test within 7 days before the first dose must be negative;
Agree to use contraceptive measures with an annual failure rate <1% or maintain abstinence (avoid heterosexual intercourse) (from signing the informed consent form until at least 120 days after the last dose of the study drug, and at least 9 months after surgery) (contraceptive methods with an annual failure rate <1% include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper-containing intrauterine devices.);
Must not breastfeed.
Male patients must meet:
Agree to abstinence (avoid heterosexual intercourse) or use contraceptive measures, as specified below: when the partner is a woman of childbearing potential or the partner is pregnant, male patients must maintain abstinence or correctly use condoms for at least 120 days after the last dose of the study drug and at least 9 months after surgery. The reliability of sexual abstinence should be evaluated with reference to the duration of the clinical study, patient preference, and daily lifestyle. Periodic abstinence (e.g., calendar days, ovulation period, basal...)
Subjects read and fully understand the patient information and sign the informed consent form.

Who cannot join

Patients with a prior (within 5 years) or concurrent other malignancy. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, stage I lung cancer, stage I colorectal cancer, etc., may be enrolled;
Patients preparing to undergo or having previously received organ or bone marrow transplantation;
Any bleeding event of severity grade 3 or above according to CTCAE 5.0 occurring within 4 weeks before screening;
Abnormal coagulation function with a bleeding tendency (INR >1.5 of the normal value without the use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; on the premise that the prothrombin time international normalized ratio (INR) ≤1.5, low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylactic purposes is permitted;
Occurrence of arterial/venous thrombotic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those caused by venous catheterization due to prior chemotherapy and judged by the investigator to have healed), and pulmonary embolism, etc.;
Occurrence of myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥450 ms in males and ≥470 ms in females) within 6 months before the first dose (QTc interval calculated using the Fridericia formula);

Show all 28Show fewer

Presence of NYHA class III-IV cardiac insufficiency or echocardiography: LVEF (left ventricular ejection fraction) <50%;
Urinalysis indicating urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g;
Presence of multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.);
Symptomatic pleural effusion or ascites requiring clinical intervention;
Human immunodeficiency virus (HIV) infection;
Active pulmonary tuberculosis;
Long-term non-healing wounds or incompletely healed fractures;
Prior and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of pulmonary function, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity;
Presence of known active or suspected autoimmune disease, except those in a stable state of the disease at enrollment (not requiring systemic immunosuppressive therapy);
History of severe chronic autoimmune disease, such as systemic lupus erythematosus, etc.; history of inflammatory bowel disease such as ulcerative colitis and Crohn's disease; history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis or tuberculosis; history of active hepatitis B, hepatitis C, and HIV infection; well-controlled non-severe immune diseases such as dermatitis, arthritis, psoriasis, etc., may be enrolled. Hepatitis B virus titer <500 copies/mL may be enrolled;
Patients requiring systemic corticosteroids (>10 mg/day prednisone-equivalent dose) or other immunosuppressive therapy within 14 days before the first dose or during the study period. However, the following conditions are permitted for enrollment: in the absence of active autoimmune disease, patients are permitted to use topical or inhaled steroids, or adrenal hormone replacement therapy at a dose ≤10 mg/day prednisone-equivalent dose;
Any active infection requiring systemic anti-infective treatment within 14 days before the first dose; except for receiving prophylactic antibiotic treatment (such as prevention of urinary tract infection or chronic obstructive pulmonary disease);
Treatment with live vaccines within 28 days before the first dose; except for inactivated viral vaccine treatment for seasonal influenza;
Prior treatment with antibody/drug therapy targeting immune checkpoints, such as PD-1, PD-L1, CTLA-4 inhibitors, etc.;
Treatment with immune-related drugs or medical technologies within 6 months before the first dose (including but not limited to the following: thymopentin, thymalfasin, interferon, CAR-T therapy, etc.);
Currently receiving other drug-related clinical study treatment, or the planned start time of this study treatment is less than 1 month from the end of the previous drug-related clinical study treatment;
Known history of allergy or intolerance to any study drug or its components;
Patients with a history of alcoholism, drug use, and drug abuse. Patients who have stopped drinking alcohol may be enrolled;
Patients with non-compliance with medical advice, non-compliance with prescribed medication, or incomplete data, etc., which may affect the assessment of efficacy or safety;
Pregnant or lactating female patients;
Patients with conditions that may increase the risk of participating in the study and study drug use, or other severe, acute, and chronic diseases, who, as judged by the investigator, are not suitable for participation in clinical research.
Other circumstances judged by the investigator as unsuitable for this clinical trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hao Xu Hao XU contact

86-2568306505

liuhongda@njmu.edu.cn

About this study

Official title: Efficacy and Safety of Intraoperative Radiotherapy Combined With Serplulimab Plus Chemotherapy Versus Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single-Center, Randomized Controlled Study

Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Being tested: Serplulimab, Intraoperative exploration plus intraoperative radiotherapy, Intraoperative exploration without intraoperative radiotherapy, Orol S-1, Oxaliplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SerplulimabDrug
Serplulimab: 300 mg, intravenous infusion, Day 1, Q3W, for a total of 3 cycles, administered synchronously with oxaliplatin
Intraoperative exploration plus intraoperative radiotherapyProcedure or surgery
Intraoperative radiotherapy is performed synchronously during intraoperative exploration:
Target volume: macroscopically visible tumor lesions and positive lymph nodes; the radiation field is determined by a 2 cm margin beyond the edge of the tumor-invaded area; normal tissues within the target area may be shielded with lead blocks.
Target dose: 9-16 MeV electron beam, radiation dose 10-12 Gy (at a depth of 2-3 cm).
Intraoperative exploration without intraoperative radiotherapyProcedure or surgery
Intraoperative exploration before drug treatment, to exclude peritoneal metastasis.
Orol S-1Drug
S-1: oral administration: 40 mg per dose for body surface area < 1.25, 50 mg per dose for body surface area ≥ 1.25 to < 1.5, 60 mg per dose for body surface area ≥ 1.5, twice daily, administered on D1-D14 of each treatment cycle, Q3W, for a total of 3 cycles;
OxaliplatinDrug
Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks as one cycle (Q3W), for a total of 3 cycles;

Study groups in NCT07870798
Study group	Role	What they receive
Experimental group	Experimental	Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks as one cycle (Q3W), for a total of 3 cycles; Serplulimab: 300 mg, intravenous infusion, Day 1, Q3W, for a total of 3 cycles, administered synchronously with oxaliplatin; S-1: oral administration: 40 mg per dose for body surface area < 1.25, 50 mg per dose for body surface area ≥ 1.25 to < 1.5, 60 mg per dose for body surface area ≥ 1.5, twice daily, administered on D1-D14 of each treatment cycle, Q3W, for a total of 3 cycles; Intraoperative radiotherapy is performed synchronously during intraoperative exploration: Target volume: macroscopically visible tumor lesions and positive lymph nodes; the radiation field is determined by a 2 cm margin beyond the edge of the tumor-invaded area; normal tissues within the target area may be shielded with lead blocks. Target dose: 9-16 MeV electron beam, radiation dose 10-12 Gy (at a depth of 2-3 cm). Receives: Drug: Serplulimab; Procedure: Intraoperative exploration plus intraoperative radiotherapy; Drug: Orol S-1; Drug: Oxaliplatin
Control group	Active comparator	Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks as one cycle (Q3W), for a total of 3 cycles; Serplulimab: 300 mg, intravenous infusion, Day 1, Q3W, for a total of 3 cycles, administered synchronously with oxaliplatin; S-1: oral administration: 40 mg per dose for body surface area < 1.25, 50 mg per dose for body surface area ≥ 1.25 to < 1.5, 60 mg per dose for body surface area ≥ 1.5, twice daily, administered on D1-D14 of each treatment cycle, Q3W, for a total of 3 cycles; Receives: Drug: Serplulimab; Procedure: Intraoperative exploration without intraoperative radiotherapy; Drug: Orol S-1; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

pCR%
Defined as the proportion of subjects with no residual viable tumor cells under microscopy and negative lymph nodes among the total subjects.
Measured: After completion of 3 cycles of neoadjuvant chemotherapy，immediately after the surgery

Secondary outcomes (2)

R0 resection rate
Defined as microscopically negative resection margins after surgical resection, i.e., no gross or microscopic tumor residual in the primary tumor bed.
Measured: Immediately after the surgery
MPR
The proportion of patients with residual viable tumor cells ≤10% in the primary tumor bed and regional lymph nodes after neoadjuvant therapy and surgical resection.
Measured: Immediately after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202631 Dec 2028

First posted13 Oct 2026
Study start15 Oct 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies 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: 68 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07870798
Sponsor's protocol ID: 2026-SR-0169
Acronym: NICT-IORT
Status last verified: Sep 2026
First submitted: 29 Sep 2026
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Intraoperative Radiotherapy Combined With Serplulimab Plus Chemotherapy Versus Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single-Center, Randomized Controlled Study
ClinicalTrials.gov ID: NCT07870798
Acronym / sponsor ID: NICT-IORT / 2026-SR-0169
Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 68 participants (estimated)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: 15 Oct 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 13 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: Serplulimab, Procedure: Intraoperative exploration plus intraoperative radiotherapy, Drug: Orol S-1, Drug: OxaliplatinOxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks as one cycle (Q3W), for a total of 3 cycles; Serplulimab: 300 mg, intravenous infusion, Day 1, Q3W, for a total of 3 cycles, administered synchronously with oxaliplatin; S-1: oral administration: 40 mg per dose for body surface area < 1.25, 50 mg per dose for body surface area ≥ 1.25 to < 1.5, 60 mg per dose for body surface area ≥ 1.5, twice daily, administered on D1-D14 of each treatment cycle, Q3W, for a total of 3 cycles; Intraoperative radiotherapy is performed synchronously during intraoperative exploration: Target volume: macroscopically visible tumor lesions and positive lymph nodes; the radiation field is determined by a 2 cm margin beyond the edge of the tumor-invaded area; normal tissues within the target area may be shielded with lead blocks. Target dose: 9-16 MeV electron beam, radiation dose 10-12 Gy (at a depth of 2-3 cm).
Control group	Active comparator	Drug: Serplulimab, Procedure: Intraoperative exploration without intraoperative radiotherapy, Drug: Orol S-1, Drug: OxaliplatinOxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks as one cycle (Q3W), for a total of 3 cycles; Serplulimab: 300 mg, intravenous infusion, Day 1, Q3W, for a total of 3 cycles, administered synchronously with oxaliplatin; S-1: oral administration: 40 mg per dose for body surface area < 1.25, 50 mg per dose for body surface area ≥ 1.25 to < 1.5, 60 mg per dose for body surface area ≥ 1.5, twice daily, administered on D1-D14 of each treatment cycle, Q3W, for a total of 3 cycles;

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

Patients aged 18-75 years with gastric or gastroesophageal junction adenocarcinoma, male or female;
According to the AJCC 8th edition gastric cancer staging, patients assessed by abdominal CT as cStage III (cT3-4aN1-3M0), and diagnosed with gastric or gastroesophageal junction adenocarcinoma by gastroscopy and pathology; for gastroesophageal junction (GEJ) cancer, only Siewert type III and Siewert type II subjects who do not require combined thoracotomy are allowed to be enrolled.
Before enrollment, after joint assessment by a attending gastrointestinal surgeon and an imaging technician, the tumor is determined to be cStage III and the patient is eligible for curative-intent R0 resection; the patient agrees to undergo radical surgery and is judged by the surgeon to have no surgical contraindications;
No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy/immunotherapy, etc.;
Expected survival ≥6 months;

Key exclusion criteria (28 listed)

Patients with a prior (within 5 years) or concurrent other malignancy. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, stage I lung cancer, stage I colorectal cancer, etc., may be enrolled;
Patients preparing to undergo or having previously received organ or bone marrow transplantation;
Any bleeding event of severity grade 3 or above according to CTCAE 5.0 occurring within 4 weeks before screening;
Abnormal coagulation function with a bleeding tendency (INR >1.5 of the normal value without the use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; on the premise that the prothrombin time international normalized ratio (INR) ≤1.5, low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylactic purposes is permitted;
Occurrence of arterial/venous thrombotic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those caused by venous catheterization due to prior chemotherapy and judged by the investigator to have healed), and pulmonary embolism, etc.;

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
SerplulimabSerplulimab: 300 mg, intravenous infusion, Day 1, Q3W, for a total of 3 cycles, administered synchronously with oxaliplatin	Drug	Control group, Experimental group
Intraoperative exploration plus intraoperative radiotherapyIntraoperative radiotherapy is performed synchronously during intraoperative exploration: Target volume: macroscopically visible tumor lesions and positive lymph nodes; the radiation field is determined by a 2 cm margin beyond the edge of the tumor-invaded area; normal tissues within the target area may be shielded with lead blocks. Target dose: 9-16 MeV electron beam, radiation dose 10-12 Gy (at a depth of 2-3 cm).	Procedure or surgery	Experimental group
Intraoperative exploration without intraoperative radiotherapyIntraoperative exploration before drug treatment, to exclude peritoneal metastasis.	Procedure or surgery	Control group
Orol S-1S-1: oral administration: 40 mg per dose for body surface area < 1.25, 50 mg per dose for body surface area ≥ 1.25 to < 1.5, 60 mg per dose for body surface area ≥ 1.5, twice daily, administered on D1-D14 of each treatment cycle, Q3W, for a total of 3 cycles;	Drug	Control group, Experimental group
OxaliplatinOxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks as one cycle (Q3W), for a total of 3 cycles;	Drug	Control group, Experimental group

Primary outcome

pCR%
Time frame: After completion of 3 cycles of neoadjuvant chemotherapy，immediately after the surgery
Defined as the proportion of subjects with no residual viable tumor cells under microscopy and negative lymph nodes among the total subjects.

2 secondary outcomes

R0 resection rate
Time frame: Immediately after the surgery
MPR
Time frame: Immediately after the 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 13 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Gastric or Gastroesophageal Junction Adenocarcinoma

RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

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.

Hao Xu Hao XU contact

86-2568306505

liuhongda@njmu.edu.cn

Questions about this trial

What is this clinical trial studying?

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 25 inclusion and 28 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Hao Xu Hao XU (86-2568306505, liuhongda@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR% (time frame: After completion of 3 cycles of neoadjuvant chemotherapy，immediately after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07870798.

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 13 Oct 2026.