Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2RARENCT05941481
Neoadjuvant Chemo-hypoRT Plus PD-1 Antibody (Tislelizumab) in Resectable LA-G/GEJ
A Phase 2 study testing neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
Gastric cancer is the third leading cause of death due to cancer worldwide. Although the consensus on the surgical treatment has resulted in the improvement of curative effect during the past decades, controversies remained for the perioperative therapy of gastric cancer, especially in the selection of the optimal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 20 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma involving the gastroesophageal junction or gastric cardia.
- Having an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before enrollment.
- Being histologically diagnosed with adenocarcinoma.
- Having tumor lesions at stomach or gastroesophageal junction (Siewert type II or III);
- Clinically diagnosed stage T1-2N+M0/T3-T4aNanyM0 according to ultrasound endoscopy or enhanced CT/MRI scan.
- At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
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- Surgical consultation at enrolling site to confirm that patient will be able to undergo curative resection after completion of neoadjuvant therapy =< 56 days prior to registration.
- Physical condition and adequate organ function to ensure the success of abdominal surgery.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
- Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- Male or female. Age ≥ 18 years and ≤80 years.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Female patients should not be pregnant or breast feeding.
- Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.
Who cannot join
- Patients with distant metastasis or unresectable primary lesion.
- Received prior treatment or receiving current treatment for this malignancy.
- Patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
- Perforation / fistula of GI tract in 6 months before recruitment.
- Patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of apecitabine.
- Patients with active autoimmune disease or history of refractory autoimmune disease.
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- Patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
- Uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment.
- Pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease.
- Uncontrollable systemic diseases, including diabetes, hypertension, etc.
- Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc.
- Patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA.
- Patients with any cardiovascular risk factors below:
- cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity.
- pulmonary embolism with symptoms occurring in 28 days before recruitment.
- acute myocardial infarction occurring in 6 months before recruitment.
- any history of heart failure reaching grade 3/4 of NYHA in 6 months before recruitment.
- ventricular arrhythmias of Grade 2 or grater in 6 months before recruitment, or accompanied by supraventricular tachyarrhythmias requiring medical treatment.
- cerebrovascular accident within 6 months before recruitment.
- Moderate or severe renal injury [creatinine clearance rate≤50 ml/min (according to Cockroft \& Gault equation)], or Scr>ULN.
- Dipyrimidine dehydrogenase (DPD) deficiency.
- Allergic to any drug in this study.
- History of allogeneic stem cell transplantation or organ transplantation.
- Use of steroids (dosage>10mg/d prednisone) or other systemic immune suppressive therapy in 14 days before recruitment, except patients treated with regimens below: a. steroids for hormone replacement (dosage>10mg/d prednisone); b. steroids for local application with little systemic absorption; c. short -term (≤ 7 days) steroids for preventing allergy or vomiting.
- Vaccinated with live vaccine in 4 weeks before recruitment.
- Receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment.
- Receiving palliative radiation in 14 days before recruitment.
- History of anti PD-1, PD-L1, PD-L2 or any other specific T cell co-stimulation or checkpoint pathway targeted treatment.
- Patients who lose ≥20% of body weight within 2 months before enrollment.
- For patients with uncontrolled epilepsy, CNS diseases or history of mental disorder, researchers should evaluate whether their diseases will impede their signing of informed consent or compliance of treatment.
- Existing of potential situation which will impede drug administration or affect toxicity analysis or alcohol/ drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Chemo-hypofractionated Radiotherapy Plus PD-1 Antibody (Tislelizumab) in Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric cancer is the third leading cause of death due to cancer worldwide. Although the consensus on the surgical treatment has resulted in the improvement of curative effect during the past decades, controversies remained for the perioperative therapy of gastric cancer, especially in the selection of the optimal neoadjuvant regimens. Immunotherapy with anti-programmed cell death-1 (PD-1) antibody has demonstrated moderate efficacy in selected patients with advanced gastric adenocarcinoma. Hypofractionated radiotherapy (HypoRT) may act synergistically with immunotherapy to enhance antitumor responses. This phase II trial study want to exploit the efficacy and safety to give PD-1 antibody (Tislelizumab) with combination chemotherapy and HypoRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.
Read the detailed description
- This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 9 participants, if ≥1 participants acquire remission, then the study will move on to the second stage and enroll the rest 10 participants. Taking into account a drop-out rate of about 5%, we planned to enroll 21 patients.
- Target population: patients with resectable locally advanced resectable gastric or gastroesophageal junction adenocarcinoma (cT1-2N+M0/T3-T4aNanyM0).
- Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma.
- Being tested
- neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab)
- Keywords
- gastric or gastroesophageal junction adenocarcinoma, neoadjuvant chemo-hypofractionated radiotherapy, PD-1 Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab)Combination product
- Immunotherapy combined with chemotherapy (2 cycles): Intravenous tislelizumab (200mg, d1, q21d) in combination with XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, q21d);
- Concurrent radiotherapy: Within one week after the first initiation of chemo-immunotherapy, concurrent hypofractionated radiotherapy will be started: intensity modulated radiotherapy was given for tumors, total dose:30Gy/12f, 2.5Gy/f.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody | Experimental | 1. Immunotherapy combined with chemotherapy (2 cycles): Intravenous tislelizumab (200mg, d1, q21d) in combination with XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, q21d);
2. Concurrent radiotherapy: Within one week after the first initiation of chemo-immunotherapy, concurrent hypofractionated radiotherapy will be started: intensity modulated radiotherapy was given for tumors, total dose:30Gy/12f, 2.5Gy/f.
3. D2 resection will be received three to five weeks after the completion of neoadjuvant therapy. Receives: Combination Product: neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission (pCR) rate
Pathologic complete response was defined as pT0N0M0
Measured: From date of treatment allocation and during treatment period up to 1 year
Secondary outcomes (7)
Radiographic response
To assess radiographic response to neoadjuvant tislelizumab with concurrent chemoradiotherapy using RECIST 1.1.
Measured: From date of treatment allocation and during treatment period up to 3 months
The R0 resection rate
Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate
Measured: Up to 3 years
Safety of neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) Safety of neoadjuvant therapy
Adverse events (AE) of neoadjuvant therapy will be graded and documented according to NCI-CTCAE v5.0 from the beginning of treatment to 1 month after the last date of treatment.
Measured: 1 month after the last date of treatment
Postoperative complications
Using the Clavien-Dindo classification
Measured: AEs of surgery refer to complications which happen during or in 30 days after operation.
Time to Relapse (TTR)
The median TTR and confidence interval will be estimated using the method of Kaplan-Meier
Measured: Time from the date of study registration to the date of 1st documented relapse/recurrence among patients who achieve R- resection, assessed up to 3 years
Progression-free Survival (PFS)
The distribution of PFS will be estimated using the method of Kaplan-Meier.
Measured: Time from the date of study registration to the date of death due to all causes, recurrences if R0 resections are achieved, progression disease before undergoing surgery, or R1/R2 resection at surgery, whichever comes first, assessed up to 3 years
Overall Survival (OS)
The distribution of OS will be estimated using the method of Kaplan-Meier.
Measured: Time from the date of study registration to the date of death due to all causes, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start10 Jun 2023
- Primary completion15 Mar 2025
- Study completion20 Jun 2026
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Chen, Jiangsu Cancer Institute & Hospital
- Investigators
- Cheng Chen, doctor, Principal investigator, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941481
- Sponsor's protocol ID
- jsCANCER
- Acronym
- RARE
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemo-hypofractionated Radiotherapy Plus PD-1 Antibody (Tislelizumab) in Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05941481
- Acronym / sponsor ID
- RARE / jsCANCER
- Keywords
- gastric or gastroesophageal junction adenocarcinoma, neoadjuvant chemo-hypofractionated radiotherapy, PD-1 Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 12 Jul 2023 (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.
Gastric cancer is the third leading cause of death due to cancer worldwide. Although the consensus on the surgical treatment has resulted in the improvement of curative effect during the past decades, controversies remained for the perioperative therapy of gastric cancer, especially in the selection of the optimal neoadjuvant regimens. Immunotherapy with anti-programmed cell death-1 (PD-1) antibody has demonstrated moderate efficacy in selected patients with advanced gastric adenocarcinoma. Hypofractionated radiotherapy (HypoRT) may act synergistically with immunotherapy to enhance antitumor responses. This phase II trial study want to exploit the efficacy and safety to give PD-1 antibody (Tislelizumab) with combination chemotherapy and HypoRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.
Detailed description
- This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 9 participants, if ≥1 participants acquire remission, then the study will move on to the second stage and enroll the rest 10 participants. Taking into account a drop-out rate of about 5%, we planned to enroll 21 patients.
- Target population: patients with resectable locally advanced resectable gastric or gastroesophageal junction adenocarcinoma (cT1-2N+M0/T3-T4aNanyM0).
- Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody | Experimental | Combination Product: neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab)1. Immunotherapy combined with chemotherapy (2 cycles): Intravenous tislelizumab (200mg, d1, q21d) in combination with XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, q21d); 2. Concurrent radiotherapy: Within one week after the first initiation of chemo-immunotherapy, concurrent hypofractionated radiotherapy will be started: intensity modulated radiotherapy was given for tumors, total dose:30Gy/12f, 2.5Gy/f. 3. D2 resection will be received three to five weeks after the completion of neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed adenocarcinoma involving the gastroesophageal junction or gastric cardia.
- Having an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before enrollment.
- Being histologically diagnosed with adenocarcinoma.
- Having tumor lesions at stomach or gastroesophageal junction (Siewert type II or III);
- Clinically diagnosed stage T1-2N+M0/T3-T4aNanyM0 according to ultrasound endoscopy or enhanced CT/MRI scan.
Key exclusion criteria (31 listed)
- Patients with distant metastasis or unresectable primary lesion.
- Received prior treatment or receiving current treatment for this malignancy.
- Patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
- Perforation / fistula of GI tract in 6 months before recruitment.
- Patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of apecitabine.
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 |
|---|---|---|
| neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab)1. Immunotherapy combined with chemotherapy (2 cycles): Intravenous tislelizumab (200mg, d1, q21d) in combination with XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, q21d); 2. Concurrent radiotherapy: Within one week after the first initiation of chemo-immunotherapy, concurrent hypofractionated radiotherapy will be started: intensity modulated radiotherapy was given for tumors, total dose:30Gy/12f, 2.5Gy/f. | Combination product | neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody |
Primary outcome
pathological complete remission (pCR) rate
Time frame: From date of treatment allocation and during treatment period up to 1 year
Pathologic complete response was defined as pT0N0M0
7 secondary outcomes
Radiographic response
Time frame: From date of treatment allocation and during treatment period up to 3 months
The R0 resection rate
Time frame: Up to 3 years
Safety of neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) Safety of neoadjuvant therapy
Time frame: 1 month after the last date of treatment
Postoperative complications
Time frame: AEs of surgery refer to complications which happen during or in 30 days after operation.
Time to Relapse (TTR)
Time frame: Time from the date of study registration to the date of 1st documented relapse/recurrence among patients who achieve R- resection, assessed up to 3 years
Progression-free Survival (PFS)
Time frame: Time from the date of study registration to the date of death due to all causes, recurrences if R0 resections are achieved, progression disease before undergoing surgery, or R1/R2 resection at surgery, whichever comes first, assessed up to 3 years
Overall Survival (OS)
Time frame: Time from the date of study registration to the date of death due to all causes, assessed up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 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. This study is not recruiting at the moment.
Cheng Chen, doctor principal investigator
Jiangsu Cancer Institute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Jiangsu Cancer Institute & Hospital 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 18 inclusion and 31 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: finished, as of the sponsor's last update on 2 Jul 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete remission (pCR) rate (time frame: From date of treatment allocation and during treatment period up to 1 year). 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 2 Jul 2026.