Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT07072351
Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastroesophageal Junction Adenocarcinoma
A Phase 1/2 study testing hypofractionated radiotherapy, SOX Chemotherapy and PD-1 inhibitor 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 conversion therapy using HFRT combined with ICT in locally advanced or metastatic unresectable 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, Immunotherapy
- What is being tested?
- hypofractionated radiotherapy, SOX Chemotherapy and PD-1 inhibitor
- 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
- 88 participants
- Where
- 4 sitesChina
- Study dates
- 15 Sep 2025to 14 May 2028
- 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
- Participants must meet all of the following criteria:
- Histologically and/or cytologically confirmed diagnosis of locally advanced gastroesophageal junction adenocarcinoma (GEJA), Siewert type I-III, with staging of cT3-4, any N, M0 or cT2 N+, M0, according to the AJCC 8th edition.
- Resectable locally advanced disease as determined by multidisciplinary team (MDT) assessment.
- Age ≥18 years, regardless of sex.
- ECOG performance status of 0 or 1.
- Estimated life expectancy of ≥3 months.
Show all 38Show fewer
- No prior anti-tumor therapy.
- At least one measurable lesion per RECIST v1.1, defined as:
- Lesion ≥1 cm in longest diameter on spiral CT, or
- Lesion ≥2 cm in longest diameter on conventional CT or MRI.
- Imaging must be performed within 28 days prior to enrollment.
- Adequate organ function within 14 days prior to treatment, as defined below (Note: No RBC or platelet transfusion or use of G-CSF within 14 days prior to hematology testing):
- Hematologic:
- Hemoglobin ≥9 g/dL (without transfusion)
- ANC ≥1.5 × 10⁹/L
- WBC ≥3.0 × 10⁹/L (without G-CSF)
- Platelets ≥75 × 10⁹/L (without IL-11 or TPO)
- Biochemical:
- 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)
- Albumin ≥25 g/L (2.5 g/dL)
- Coagulation (within 7 days prior to enrollment):
- INR <1.5
- APTT <1.5 × ULN
- INR or PT ≤1.5 × ULN
- For patients with active hepatitis B or C:
- Antiviral therapy must be initiated ≥14 days before enrollment
- HBV DNA ≤500 IU/mL or ≤2500 copies/mL; HCV RNA undetectable
- Must agree to continue antiviral therapy during the study
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiography.
- Women of childbearing potential:
- Negative serum or urine pregnancy test within 7 days prior to enrollment
- Agree to use effective contraception during the study and for at least 3 months after the last dose
- Must not breastfeed or donate/retrieve ova within 60 days after the last dose
- Effective contraception must be continued for at least 6 months after last dose of chemotherapy
- Men must be surgically sterile or agree to use effective contraception during the study and for at least 3 months after the last dose.
- Voluntarily signed informed consent with good compliance and willingness to complete study procedures and follow-up.
Who cannot join
- Participants who meet any of the following conditions will be excluded:
- Diagnosed as mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) by immunohistochemistry or gene testing.
- Evidence of peritoneal or multi-organ metastatic disease, as confirmed by chest and abdominal CT, bone scan, or MRI (in cases with suspected osseous lesions).
- History of or concurrent other malignancies within the past 5 years, excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Known allergy to any component of the investigational drugs, history of severe hypersensitivity, or any contraindication to study drugs.
- Clinically significant upper gastrointestinal bleeding within 30 days prior to enrollment or randomization.
Show all 50Show fewer
- History of congenital pulmonary fibrosis, drug-induced pneumonitis, active pulmonary tuberculosis, or CT-confirmed active pneumonia; interstitial lung disease requiring steroid treatment.
- Active autoimmune or inflammatory diseases requiring immunosuppressive therapy within 2 years prior to treatment, including but not limited to:
- Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, diverticulitis),
- Systemic lupus erythematosus,
- Sarcoidosis,
- Tuberculosis,
- Wegener's granulomatosis,
- Myasthenia gravis,
- Graves' disease,
- Rheumatoid arthritis,
- Hypophysitis,
- Uveitis,
- Glomerulonephritis,
- Nephrotic syndrome,
- Fanconi syndrome, or renal tubular acidosis. Exceptions: type 1 diabetes, hypothyroidism controlled by hormone replacement, and non-systemically treated dermatologic conditions (e.g., vitiligo, psoriasis, alopecia).
- History of immunodeficiency, HIV infection (positive HIV 1/2 antibodies), congenital or acquired immunodeficiency disorders, or history of organ transplantation.
- Active hepatitis B (HBsAg positive) or active hepatitis C infection. Patients with past or controlled HBV/HCV infection may be eligible.
- Use of systemic corticosteroids or immunosuppressants within 2 weeks prior to study treatment.
- Inhaled or topical corticosteroids and adrenal replacement doses (equivalent to ≤10 mg/day prednisone) are permitted.
- Short-term (<7 days) corticosteroids are allowed for non-autoimmune conditions or prophylaxis (e.g., contrast allergy).
- Uncontrolled or serious comorbidities, including:
- Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥100 mmHg despite medication)
- Myocardial infarction, ischemia (grade II or above), acute coronary syndrome within 6 months, arrhythmia (e.g., QTc ≥480 ms, atrial fibrillation), or uncontrolled angina
- NYHA class III-IV heart failure, LVEF <50%, severe valvular disease, cardiomyopathy of any cause
- History of stroke or transient ischemic attack within screening period
- Active or uncontrolled infection
- Severe liver disease (e.g., cirrhosis, decompensated liver disease, chronic active hepatitis) affecting tolerability to treatment
- Poorly controlled diabetes (fasting glucose >10 mmol/L)
- Proteinuria ≥++ on dipstick or >1.0 g/24 h on urine protein quantification
- Coagulation disorders (INR >1.5 or APTT >1.5 × ULN), bleeding tendency, or current use of thrombolytics or anticoagulants.
- Known hereditary or acquired bleeding/thrombotic conditions (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism).
- History of significant hemoptysis (≥2.5 mL/day) or massive bleeding within 2 months.
- Gastrointestinal bleeding, bleeding gastric ulcer, positive fecal occult blood (++ or above), vasculitis, or active bleeding within 3 months.
- Long-term use of warfarin/heparin or high-dose antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day).
- Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose, or planned major surgery during the study period.
- Gastrointestinal perforation and/or fistula within 6 months prior to enrollment; history of arterial/venous thrombotic events such as stroke (excluding clinically stable infarction per investigator), deep vein thrombosis, or pulmonary embolism.
- Unhealed wounds or fractures of clinical significance.
- Severe gastrointestinal conditions that may impair oral medication absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Severe malnutrition.
- Pregnant or breastfeeding women, or subjects (male or female within one year of menopause) unwilling to use effective contraception.
- History of substance abuse or uncontrolled psychiatric disorders.
- Unwilling or unable to comply with study procedures.
- Participation in another interventional clinical trial within 30 days prior to first dose or planning to do so during the current study.
- Any other condition deemed by the investigator to pose significant risk to patient safety or interfere with study conduct.
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 Conversion Therapy for Locally Advanced Gastroesophageal Junction Adenocarcinoma
The purpose of this study is to investigate the safety and efficacy of conversion therapy using HFRT combined with ICT in locally advanced or metastatic unresectable GEJA.
Read the detailed description
The aim of this study is to investigate whether hypofractionated radiotherapy (HFRT) combined with a PD-1 inhibitor (Sintilimab) and chemotherapy based on the SOX regimen is a safe and well-tolerated conversion strategy for patients with locally advanced or metastatic unresectable gastroesophageal junction adenocarcinoma (GEJA), and whether it can improve the objective response rate (ORR) compared to immunochemotherapy alone.
- Conditions
- Gastroesophageal Junction Adenocarcinoma, Hypofractionated Radiotherapy, Immunotherapy, Chemotherapy
- Being tested
- hypofractionated radiotherapy, SOX Chemotherapy, PD-1 inhibitor
- Keywords
- hypofractionated radiotherapy, immunotherapy, chemotherapy, ORR, conversion therapy, gastroesophageal junction adenocarcinoma
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, 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).
SOX ChemotherapyDrug
SOX chemotherapy regimen: Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1; S-1 administered orally for 14 consecutive days followed by a 7-day rest period. The dosage of S-1 is based on body surface area (BSA): 40 mg twice daily for BSA ≤1.5 m², 50 mg twice daily for BSA between 1.5-1.6 m², and 60 mg twice daily for BSA ≥1.6 m². Each cycle is repeated every 3 weeks.
PD-1 inhibitorDrug
Sintilimab 200 mg administered by intravenous infusion on Day 1 of each 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (HFRT+ICT) | Experimental | Not described Receives: Radiation: hypofractionated radiotherapy; Drug: SOX Chemotherapy; Drug: PD-1 inhibitor |
| Control Arm (nICT) | Active comparator | Not described Receives: Drug: SOX Chemotherapy; Drug: PD-1 inhibitor |
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 out of 3 patients in a given dose cohort experiences radiotherapy-related dose-limiting toxicity (DLT) within 90 days, that dose level will be considered intolerable. The next lower dose level will be defined as the MTD. The MTD cohort must include at least 6 evaluable patients.
Measured: within 3 months after the HFRT
ORR rate in Phase II
Objective Response Rate (ORR):ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as determined by investigators based on RECIST version 1.1. The initial CR or PR must be confirmed by repeat imaging at least 4 weeks after the first documentation of response.
Measured: approximately 4 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
DOR (Duration of Response)
Duration from the first documented complete response (CR) or partial response (PR) to the date of disease progression (PD) or death from any cause.
Measured: Up to 3 years
PFS (Progression-Free Survival)
Time from the first administration of the study treatment to disease progression (PD) or death from any cause, whichever occurs first.
Measured: Up to 3 years
OS (Overall Survival)
Time from the initiation of study treatment to death from any cause.
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: At baseline, during treatment, and at predefined follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start15 Sep 2025
- Primary completion14 May 2028 (estimated)
- Study completion14 May 2028 (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
- 88 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
- NCT07072351
- Sponsor's protocol ID
- GEJA-ICRT-2025-05
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 28 Nov 2025
- 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 28 Nov 2025. 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 Conversion Therapy for Locally Advanced Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07072351
- Acronym / sponsor ID
- GEJA-ICRT-2025-05
- Conditions
- Gastroesophageal Junction Adenocarcinoma, Hypofractionated Radiotherapy, Immunotherapy, Chemotherapy
- Keywords
- hypofractionated radiotherapy, immunotherapy, chemotherapy, ORR, conversion therapy, gastroesophageal junction adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 14 May 2028 (estimated)
- Study completion
- 14 May 2028 (estimated)
- First posted
- 18 Jul 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 conversion therapy using HFRT combined with ICT in locally advanced or metastatic unresectable GEJA.
Detailed description
The aim of this study is to investigate whether hypofractionated radiotherapy (HFRT) combined with a PD-1 inhibitor (Sintilimab) and chemotherapy based on the SOX regimen is a safe and well-tolerated conversion strategy for patients with locally advanced or metastatic unresectable gastroesophageal junction adenocarcinoma (GEJA), and whether it can improve the objective response rate (ORR) 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+ICT) | Experimental | Radiation: hypofractionated radiotherapy, Drug: SOX Chemotherapy, Drug: PD-1 inhibitor |
| Control Arm (nICT) | Active comparator | Drug: SOX Chemotherapy, Drug: PD-1 inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Histologically and/or cytologically confirmed diagnosis of locally advanced gastroesophageal junction adenocarcinoma (GEJA), Siewert type I-III, with staging of cT3-4, any N, M0 or cT2 N+, M0, according to the AJCC 8th edition.
- Resectable locally advanced disease as determined by multidisciplinary team (MDT) assessment.
- Age ≥18 years, regardless of sex.
- ECOG performance status of 0 or 1.
- Estimated life expectancy of ≥3 months.
Key exclusion criteria (50 listed)
- Diagnosed as mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) by immunohistochemistry or gene testing.
- Evidence of peritoneal or multi-organ metastatic disease, as confirmed by chest and abdominal CT, bone scan, or MRI (in cases with suspected osseous lesions).
- History of or concurrent other malignancies within the past 5 years, excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Known allergy to any component of the investigational drugs, history of severe hypersensitivity, or any contraindication to study drugs.
- Clinically significant upper gastrointestinal bleeding within 30 days prior to 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, 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+ICT) |
| SOX ChemotherapySOX chemotherapy regimen: Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1; S-1 administered orally for 14 consecutive days followed by a 7-day rest period. The dosage of S-1 is based on body surface area (BSA): 40 mg twice daily for BSA ≤1.5 m², 50 mg twice daily for BSA between 1.5-1.6 m², and 60 mg twice daily for BSA ≥1.6 m². Each cycle is repeated every 3 weeks. | Drug | Control Arm (nICT), Intervention Arm (HFRT+ICT) |
| PD-1 inhibitorSintilimab 200 mg administered by intravenous infusion on Day 1 of each 3-week cycle. | Drug | Control Arm (nICT), Intervention Arm (HFRT+ICT) |
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 out of 3 patients in a given dose cohort experiences radiotherapy-related dose-limiting toxicity (DLT) within 90 days, that dose level will be considered intolerable. The next lower dose level will be defined as the MTD. The MTD cohort must include at least 6 evaluable patients.
ORR rate in Phase II
Time frame: approximately 4 weeks after the resection of primary lesion
Objective Response Rate (ORR):ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as determined by investigators based on RECIST version 1.1. The initial CR or PR must be confirmed by repeat imaging at least 4 weeks after the first documentation of response.
6 secondary outcomes
R0 resection rate
Time frame: approximately 2 weeks after the resection of primary lesion
DOR (Duration of Response)
Time frame: Up to 3 years
PFS (Progression-Free Survival)
Time frame: Up to 3 years
OS (Overall Survival)
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: At baseline, during treatment, and at predefined follow-up visits
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 28 Nov 2025.
- 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
Related trials for 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
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder 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
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, SOX Chemotherapy and PD-1 inhibitor 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 38 inclusion and 50 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 28 Nov 2025. 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 28 Nov 2025.