Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT07182565
Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma
A Phase 1/2 study testing hypofractionated radiotherapy, PD-1 inhibitor and TS-1 in people with Gastroesophageal Junction Adenocarcinoma and Hypofractionated Radiotherapy, run by West China Hospital at 4 sites in China.
Trial summary
The purpose of this study is to investigate the safety and efficacy of HFRT plus neoadjuvant ICT in locally advanced resectable GEJA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma, Hypofractionated Radiotherapy
- What is being tested?
- hypofractionated radiotherapy, PD-1 inhibitor and TS-1
- 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
- 84 participants
- Where
- 4 sitesChina
- Study dates
- 18 Nov 2025to 31 Aug 2029
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed diagnosis of locally advanced adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert types I-III), defined as cT3-4, any N, M0 or cT2 N+, M0 according to the 8th edition of the AJCC staging system.
- Determined as resectable locally advanced disease after multidisciplinary team (MDT) evaluation.
- Age ≥18 years, regardless of sex.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy ≥3 months.
- No prior anti-cancer treatment.
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- At least one measurable lesion as defined by RECIST v1.1 (lesion diameter ≥1 cm on spiral CT or ≥2 cm on standard CT or MRI), assessed within 28 days prior to enrollment.
- Adequate organ function within 14 days prior to treatment, defined as follows (note: blood transfusions, platelet infusions, or G-CSF use not permitted within 14 days prior to hematologic assessment):
- 1) Hematological: Hemoglobin ≥9 g/dL (without recent transfusion); ANC ≥1.5 × 10⁹/L; WBC ≥3.0 × 10⁹/L (no G-CSF use); Platelets ≥75 × 10⁹/L (no IL-11 or TPO use).
- 2) Biochemistry: Total bilirubin ≤1.5 × ULN; AST and ALT ≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); Serum albumin ≥25 g/L.
- 3) Coagulation: INR <1.5, APTT <1.5 × ULN within 7 days before enrollment; PT ≤1.5 × ULN.
- 9.Patients with active hepatitis B or C infection must have received antiviral therapy ≥14 days prior to enrollment, with HBV DNA ≤500 IU/mL or 2500 copies/mL, HCV RNA undetectable, and agree to continue antiviral therapy during the study.
- 10.LVEF ≥50% on echocardiography. 11.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use effective contraception during the study and for at least 3 months after the last dose. Males must use effective contraception during and for at least 3 months after treatment. Female participants must not be breastfeeding or donate/retrieve ova within 60 days after the last dose.
- 12.Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Confirmed dMMR or MSI-H by immunohistochemistry or genetic testing.
- Evidence of peritoneal or visceral metastasis (based on thoracoabdominal CT, bone scan, or MRI if bone metastasis is suspected).
- Other malignancies within the past 5 years, except cured basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Known allergy or hypersensitivity to any study drugs or their excipients; contraindications to study drugs.
- Clinically significant upper gastrointestinal bleeding within 30 days before enrollment or randomization.
- Interstitial lung disease, pulmonary fibrosis, active tuberculosis, or steroid-requiring pneumonitis confirmed by CT.
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- Active autoimmune or inflammatory disease requiring immunosuppressants within 2 years (e.g., IBD, SLE, sarcoidosis, Wegener's, MG, Graves', rheumatoid arthritis, etc.); exceptions: well-controlled type 1 diabetes, hypothyroidism under hormone replacement, untreated localized skin diseases (e.g., vitiligo, psoriasis).
- Immunodeficiency, history of HIV infection or organ transplantation.
- Active HBV (HBsAg positive) or HCV infection. Previously treated or well-controlled HBV/HCV is allowed.
- Systemic corticosteroids or immunosuppressants within 2 weeks prior to treatment. Exceptions: inhaled or local steroids, adrenal replacement (<10 mg/day prednisone equivalent), or short-term corticosteroids (<7 days) for prophylaxis or non-autoimmune indications.
- Uncontrolled comorbidities, including:
- 1）Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥100 mmHg); 2）Grade II+ myocardial ischemia or MI within 6 months, arrhythmia (QT ≥480 ms, AF), uncontrolled angina, CHF (NYHA III-IV), valvular disease, cardiomyopathy, stroke or TIA history; 3）Active or uncontrolled infection; 4）Liver disease (cirrhosis, decompensation, active hepatitis); 5）Poorly controlled diabetes (FBG >10 mmol/L); 6）Proteinuria ≥++ or 24h urine protein >1.0 g. 12.Coagulation abnormalities (INR >1.5 or APTT >1.5 × ULN), known bleeding tendency, or patients receiving thrombolytic or anticoagulant therapy. Known congenital or acquired bleeding or thrombotic disorders, such as hemophilia, coagulation defects, thrombocytopenia, hypersplenism, etc.
- Patients with significant hemoptysis (≥2.5 mL per day), or a history of clinically significant bleeding (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcers, or fecal occult blood test ≥++) within 3 months prior to enrollment.
- Patients requiring long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day).
- 13.Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dose, or expected to undergo major surgery during the study, or non-diagnostic surgery within 4 weeks prior to trial initiation.
- 14.History of gastrointestinal perforation and/or fistula within 6 months before enrollment; or history of arterial or venous thromboembolic events, such as stroke (except stable cerebral infarction as judged by the investigator), deep vein thrombosis, or pulmonary embolism.
- 15.Long-term unhealed wounds or fractures. 16.Severe gastrointestinal conditions that may interfere with oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- 17.Severe malnutrition. 18.Pregnant or lactating women, or participants of reproductive potential (male or female not postmenopausal for at least one year) who are unwilling to use effective contraception.
- 19.History of substance abuse or uncontrolled psychiatric illness. 20.Unwillingness or inability to comply with study requirements. 21.Participation in another clinical trial within 30 days prior to study entry, or planning to participate in another trial during the study period.
- 22.Any severe or uncontrolled medical condition, judged by the investigator to potentially compromise patient safety or interfere with study completion.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
The Seventh People's Hospital of Chengdu
Chengdu, Sichuan, 610041
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
- Recruiting
West China Shangjin Nanfu Hospital, Sichuan University
Chengdu, Sichuan, 610041
- Recruiting
West China Xiamen Hospital, Sichuan University
Xiamen, Fujian
About this study
Official title: A Phase Ib/II Study of Hypofractionated Radiotherapy Combined With Immunochemotherapy as Neoadjuvant Treatment for Adenocarcinoma of the Gastroesophageal Junction
The purpose of this study is to investigate the safety and efficacy of HFRT plus neoadjuvant ICT in locally advanced resectable GEJA.
Read the detailed description
The aim of this study is to investigate whether hypofractionated radiotherapy combined with a PD-1 inhibitor (Serplulimab) and chemotherapy based on the TS regimen is a safe and well-tolerated neoadjuvant strategy for patients with locally advanced resectable gastroesophageal junction adenocarcinoma (GEJA), and whether it can improve the pathological complete response (pCR) rate compared to immunochemotherapy alone.
- Being tested
- hypofractionated radiotherapy, PD-1 inhibitor, TS-1
- Keywords
- neoadjuvant therapy, hypofractionated radiotherapy, immunotherapy, chemotherapy, Serplulimab, pCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiotherapyRadiation
Also called HFRT, LFRT
In Phase Ib, hypofractionated radiotherapy (HFRT) will be administered at one of three dose levels: 3 Gy × 5 fractions, 4 Gy × 5 fractions, or 5 Gy × 5 fractions. The recommended dose determined in Phase Ib will be used in Phase II (delivered as 5 fractions).
PD-1 inhibitorDrug
Serplulimab will be administered concurrently with chemotherapy at a fixed dose of 300 mg via intravenous infusion on Day 1 of each 3-week cycle.
TS-1Drug
The TS regimen includes paclitaxel at a dose of 175 mg/m² administered via intravenous infusion on Day 1, and oral administration of tegafur-gimeracil-oteracil (S-1) for 14 consecutive days followed by a 7-day rest period (21-day cycle). The S-1 dose is based on body surface area (BSA): 40 mg twice daily (bid) for BSA ≤ 1.5 m²; 50 mg bid for BSA 1.5-1.6 m²; and 60 mg bid for BSA ≥ 1.6 m².
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (HFRT+nICT) | Experimental | Not described Receives: Radiation: hypofractionated radiotherapy; Drug: PD-1 inhibitor; Drug: TS-1 |
| Control Arm (nICT) | Active comparator | Not described Receives: Drug: PD-1 inhibitor; Drug: TS-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability in Phase Ib
Safety will be assessed based on clinical adverse events, vital signs, and abnormalities in laboratory tests during the study period.
Adverse events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
All deaths occurring within 90 days after the first dose of treatment or within 30 days after the last dose will be listed along with the causes of death.
Laboratory abnormalities will be categorized according to NCI-CTCAE version 5.0.
Maximum Tolerated Dose (MTD): If ≥1/3 of patients in a given dose cohort experience radiotherapy-related dose-limiting toxicities (DLTs) within 90 days, that dose level will be considered intolerable. The dose level immediately below will then be defined as the maximum tolerated dose (MTD). At least six evaluable patients are required in the MTD cohort.
Measured: within 3 months after the HFRT
pCR rate in Phase II
pCR rate: The proportion of patients who achieve pathological complete response (pCR), defined as the absence of viable tumor cells on microscopic examination after neoadjuvant therapy.
Measured: approximately 2 weeks after the resection of primary lesion
Secondary outcomes (6)
R0 resection rate
number of R0 surgery divide all participants
Measured: approximately 2 weeks after the resection of primary lesion
Objective response rate
Objective response rate (ORR) is defined as the proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A response (CR or PR) requires confirmation by a repeat assessment performed no less than 4 weeks after the criteria for response are first met.
Measured: From Baseline up to the pre-surgical assessment (performed within 28 days after the last dose of conversion therapy)
DFS(disease free survival) rate
evaluate the DFS rate after the resection of primary lesion（only patients who acquire R0 resection）
Measured: Up to 3 years
OS(overall survival) rate
evaluate the OS rate after the neoadjuvant therapy
Measured: Up to 3 years
Adverse Events (AEs)
The incidence, severity, and relationship of adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: From the first dose through 90 days after the last dose
Quality of Life (QoL) - EORTC QLQ-C30
Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Measured: Assessments are performed at Baseline, on Day 1 of each subsequent treatment cycle (each cycle is 21 days), at the end-of-treatment visit, and at 1, 3, 6, and 12 months post-surgery during follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start18 Nov 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaqin Zhao, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182565
- Sponsor's protocol ID
- GEJA-nICRT-2025-05
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD(individual patient data) Sharing Plan: Shared for: scientific research institutions, academic journal editors, government agencies Sharing conditions: IPD sharing shall meet the following conditions: Requestor must provide study agreement and relevant ethical review committee approval documents Requestor must ensure legality of data use and privacy protection Requestor must agree to data sharing, and the study team has the right to review the Requestor 's study plan and provide necessary support and interpretation of data Scope of shared data: The shared data includes ECG and clinical data of all subjects, but excluding personal information of subjects
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of Hypofractionated Radiotherapy Combined With Immunochemotherapy as Neoadjuvant Treatment for Adenocarcinoma of the Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT07182565
- Acronym / sponsor ID
- GEJA-nICRT-2025-05
- Keywords
- neoadjuvant therapy, hypofractionated radiotherapy, immunotherapy, chemotherapy, Serplulimab, pCR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 19 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.
The purpose of this study is to investigate the safety and efficacy of HFRT plus neoadjuvant ICT in locally advanced resectable GEJA.
Detailed description
The aim of this study is to investigate whether hypofractionated radiotherapy combined with a PD-1 inhibitor (Serplulimab) and chemotherapy based on the TS regimen is a safe and well-tolerated neoadjuvant strategy for patients with locally advanced resectable gastroesophageal junction adenocarcinoma (GEJA), and whether it can improve the pathological complete response (pCR) rate compared to immunochemotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (HFRT+nICT) | Experimental | Radiation: hypofractionated radiotherapy, Drug: PD-1 inhibitor, Drug: TS-1 |
| Control Arm (nICT) | Active comparator | Drug: PD-1 inhibitor, Drug: TS-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically and/or cytologically confirmed diagnosis of locally advanced adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert types I-III), defined as cT3-4, any N, M0 or cT2 N+, M0 according to the 8th edition of the AJCC staging system.
- Determined as resectable locally advanced disease after multidisciplinary team (MDT) evaluation.
- Age ≥18 years, regardless of sex.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy ≥3 months.
Key exclusion criteria (20 listed)
- Confirmed dMMR or MSI-H by immunohistochemistry or genetic testing.
- Evidence of peritoneal or visceral metastasis (based on thoracoabdominal CT, bone scan, or MRI if bone metastasis is suspected).
- Other malignancies within the past 5 years, except cured basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Known allergy or hypersensitivity to any study drugs or their excipients; contraindications to study drugs.
- Clinically significant upper gastrointestinal bleeding within 30 days before enrollment or randomization.
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 |
|---|---|---|
| hypofractionated radiotherapyAlso: HFRT, LFRTIn Phase Ib, hypofractionated radiotherapy (HFRT) will be administered at one of three dose levels: 3 Gy × 5 fractions, 4 Gy × 5 fractions, or 5 Gy × 5 fractions. The recommended dose determined in Phase Ib will be used in Phase II (delivered as 5 fractions). | Radiation | Intervention Arm (HFRT+nICT) |
| PD-1 inhibitorSerplulimab will be administered concurrently with chemotherapy at a fixed dose of 300 mg via intravenous infusion on Day 1 of each 3-week cycle. | Drug | Control Arm (nICT), Intervention Arm (HFRT+nICT) |
| TS-1The TS regimen includes paclitaxel at a dose of 175 mg/m² administered via intravenous infusion on Day 1, and oral administration of tegafur-gimeracil-oteracil (S-1) for 14 consecutive days followed by a 7-day rest period (21-day cycle). The S-1 dose is based on body surface area (BSA): 40 mg twice daily (bid) for BSA ≤ 1.5 m²; 50 mg bid for BSA 1.5-1.6 m²; and 60 mg bid for BSA ≥ 1.6 m². | Drug | Control Arm (nICT), Intervention Arm (HFRT+nICT) |
Primary outcome
Safety and tolerability in Phase Ib
Time frame: within 3 months after the HFRT
Safety will be assessed based on clinical adverse events, vital signs, and abnormalities in laboratory tests during the study period. Adverse events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. All deaths occurring within 90 days after the first dose of treatment or within 30 days after the last dose will be listed along with the causes of death. Laboratory abnormalities will be categorized according to NCI-CTCAE version 5.0. Maximum Tolerated Dose (MTD): If ≥1/3 of patients in a given dose cohort experience radiotherapy-related dose-limiting toxicities (DLTs) within 90 days, that dose level will be considered intolerable. The dose level immediately below will then be defined as the maximum tolerated dose (MTD). At least six evaluable patients are required in the MTD cohort.
pCR rate in Phase II
Time frame: approximately 2 weeks after the resection of primary lesion
pCR rate: The proportion of patients who achieve pathological complete response (pCR), defined as the absence of viable tumor cells on microscopic examination after neoadjuvant therapy.
6 secondary outcomes
R0 resection rate
Time frame: approximately 2 weeks after the resection of primary lesion
Objective response rate
Time frame: From Baseline up to the pre-surgical assessment (performed within 28 days after the last dose of conversion therapy)
DFS(disease free survival) rate
Time frame: Up to 3 years
OS(overall survival) rate
Time frame: Up to 3 years
Adverse Events (AEs)
Time frame: From the first dose through 90 days after the last dose
Quality of Life (QoL) - EORTC QLQ-C30
Time frame: Assessments are performed at Baseline, on Day 1 of each subsequent treatment cycle (each cycle is 21 days), at the end-of-treatment visit, and at 1, 3, 6, and 12 months post-surgery during follow-up.
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 6 Jan 2026.
- Individual participant dataSharing planned: Yes. IPD(individual patient data) Sharing Plan: Shared for: scientific research institutions, academic journal editors, government agencies Sharing conditions: IPD sharing shall meet the following conditions: Requestor must provide study agreement and relevant ethical review committee approval documents Requestor must ensure legality of data use and privacy protection Requestor must agree to data sharing, and the study team has the right to review the Requestor 's study plan and provide necessary support and interpretation of data Scope of shared data: The shared data includes ECG and clinical data of all subjects, but excluding personal information of subjects
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hypofractionated radiotherapy, PD-1 inhibitor and TS-1 in people with Gastroesophageal Junction Adenocarcinoma and Hypofractionated Radiotherapy, run by West China Hospital at 4 sites 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 14 inclusion and 20 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yaqin Zhao Associate Chief Physician (+86 18628260828, zhaoyaqin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability in Phase Ib (time frame: within 3 months after the HFRT). 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 6 Jan 2026.