Gastric Junction AdenocarcinomaPhase 2SNCCTGCNCT06826079
Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
A Phase 2 study testing Sorbitol + PD-1 inhibitor + SOX chemotherapy and PD-1 inhibitor + SOX chemotherapy in people with Gastric Junction Adenocarcinoma and Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Junction Adenocarcinoma, Gastric Cancer, Immunotherapy
- What is being tested?
- Sorbitol + PD-1 inhibitor + SOX chemotherapy and PD-1 inhibitor + SOX chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Aug 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years ≤ age ≤ 70 years, gender not restricted.
- Written informed consent obtained from the patient.
- Histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with clinical stage cT3-4N+M0, and histological examination confirming mainly adenocarcinoma. Only Siewert type III GEJ cancer and Siewert type II GEJ cancer patients who do not require combined thoracotomy are eligible for inclusion.
- ECOG PS score of 0-1.
- Normal major organ function, meeting the following criteria:
- Blood routine examination criteria (no blood or blood product transfusion within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction):
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- HB ≥ 90 g/L;
- ANC ≥ 1.5×109/L;
- PLT ≥ 125×109/L;
- Biochemical examination criteria:
- TBIL < 1.5ULN;
- ALT and AST < 2.5ULN, and for patients with liver metastasis, < 5ULN; serum Cr ≤ 1.25ULN or endogenous creatinine clearance rate > 50ml/min (Cockcroft-Gault formula);
- Fertile women must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization.
Who cannot join
- Presence of distant organ metastasis and peritoneal disseminated metastasis.
- Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis [excluding diverticular disease], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]), except for patients with vitiligo or alopecia, provided that they have celiac disease that can be controlled through diet after consultation with the study doctor.
- Other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.
- Patients preparing for or having previously undergone organ or bone marrow transplantation.
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV/HCV, pneumonia, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD, severe chronic gastrointestinal diseases with diarrhea, or conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or affect the ability of the subject to provide written informed consent.
- Patients currently using immunosuppressants, systemic or absorbable local hormones for immunosuppressive purposes (dose > 10mg/day prednisone or other equivalent efficacy hormones), and still using them within 2 weeks before enrollment.
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- Patients who have previously received platinum-based, fluorouracil-based chemotherapy or targeted therapy, patients whose target lesions have undergone radiotherapy during combination therapy, or patients who have previously received other PD-1 antibody treatment or other PD-1/PD-L1 immune therapy.
- Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);
- Have experienced significant clinically significant bleeding symptoms or have a clear bleeding tendency within the last three months, such as a history of black stool or hematemesis, or are at high risk of bleeding due to conditions such as intestinal perforation, gastric perforation, or extensive ulcers, or have active gastric ulcers and a positive fecal occult blood test (++) ;
- Have hypertension that cannot be well controlled with a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); have a history of unstable angina pectoris; have been newly diagnosed with angina pectoris within the last three months or have had a myocardial infarction within the last six months; have arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) and need long-term use of antiarrhythmic drugs or have New York Heart Association functional class ≥ II heart failure; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) < 50%;
- Urinalysis indicates proteinuria ≥ ++ and confirmed 24-hour urine protein quantification > 1.0 g;
- Have long-term non-healing wounds or incompletely healed fractures;
- Have abnormal coagulation function and a bleeding tendency (INR must be within the normal range without anticoagulants 14 days before enrollment); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylactic purposes is allowed if the international normalized ratio (INR) of prothrombin time is ≤ 1.5;
- Have experienced arterial or venous thrombotic events within the last year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for venous thrombosis caused by previous chemotherapy catheterization and judged by the investigator to have healed), and pulmonary embolism, etc.;
- Have a history of abuse of psychotropic drugs and are unable to quit or have mental disorders;
- Have serious concomitant diseases that, in the judgment of the investigator, pose a significant risk to the patient's safety or affect the patient's ability to complete the study;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 470000
Kaixiong Tao, Pro., 86+13294158510, kaixiongtao@hust.edu.com
About this study
Official title: Safety and Efficacy Study of Oral Sorbitol to Enhance the Therapeutic Effect of Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
The goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol. The main questions it aims to answer are:
Does sorbitol enhance the therapeutic effect of immunotherapy and increase the major response rate in patients with locally advanced gastric cancer? Does sorbitol with neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) can improve the prognosis of patients with locally advanced gastric cancer?
Read more
Researchers will compare sorbitol to a standard-of-care treatment (aPD-1 + SOX chemotherapy) to see if sorbitol works to enhance the therapeutic effect (Add-on Effect) of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer.
Participants will:
Take sorbitol every day for 3 months in 3 treatment cycles Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first). After the end of treatment and safety follow-up, all subjects will be followed up for survival (OS data collected every 3 months ±14 days).
Read the detailed description
- Overall Design This study is an exploratory investigation on the efficacy of oral sorbitol combined with SOX chemotherapy and tislelizumab (PD-1 inhibitor) in the neoadjuvant treatment of advanced gastric/gastroesophageal junction adenocarcinoma based on the concepts of tumor metabolism and immunity. The study is divided into three phases: screening period, treatment period (neoadjuvant treatment, surgery and adjuvant treatment period), and follow-up period. A total of 86 subjects will be enrolled in this study and randomly divided into two groups. Group A: oral sorbitol + PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]); Group B: PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]) (see below for details).
- Screening Period: Subjects must undergo screening and evaluation within 14 days before the first dose to determine their eligibility for the study. The specific criteria are: histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with a clinical stage of cT3-4N+M0, and histological confirmation of mainly adenocarcinoma. Only Siewert type III and Siewert type II GEJ cancer patients who do not require combined thoracotomy are allowed to be enrolled. For patients who meet the inclusion and exclusion criteria, routine blood tests, imaging examinations, and Helicobacter pylori tests will be completed, and further molecular-level tests will be conducted, including MSI status, PD-1 expression CPS score, and EBER detection of pre-treatment biopsy pathological tissues. The enrolled subjects will be randomly divided into two groups. Group A: oral sorbitol + PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]); Group B: PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]).
- Treatment Period
The treatment period will include the following phases:
- Neoadjuvant treatment (before surgery) period: 3 cycles Group A (sorbitol diet group): PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]); During the neoadjuvant treatment period, oral sorbitol 2-4g per dose, three times a day (with meals). Group B (active control group): PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]).
- Surgery: After evaluation of the efficacy of neoadjuvant treatment After neoadjuvant treatment, for subjects deemed eligible for surgery by the study, surgery should be performed within 2-6 weeks after the last dose of neoadjuvant treatment (including oral medication). For subjects who cannot undergo surgery, the subsequent treatment plan will be determined by the investigator based on the clinical situation. During the surgery, a small amount of pathological tissue should be taken and tested for AKR1B1/cGAS targets and sorbitol content.
- Adjuvant treatment (after surgery) period: 5 cycles Adjuvant treatment stage: Unblinding after surgery, adjuvant treatment can start 3 weeks to 12 weeks after surgery (beyond 12 weeks, the investigator can decide whether to continue using the experimental drug). Subjects in Group A and Group B will be grouped according to TRG grading. Subjects with TRG scores of 0-1 will continue the original treatment plan, while those with TRG scores greater than 2 will only receive SOX chemotherapy for up to 5 cycles, or until the investigator determines that the subject has lost clinical benefit, died, is intolerant to toxicity, withdraws informed consent, or for other reasons specified in the protocol (whichever occurs first).
- Follow-up Period: Including safety follow-up and survival follow-up. After the treatment ends, all subjects will be followed up. For subjects who discontinue treatment for reasons other than PD, follow-up will be conducted at the originally planned frequency until PD occurs, informed consent is withdrawn, or the subject is lost to follow-up (whichever occurs first). After the treatment ends and the safety follow-up is completed, all subjects will be followed up for survival (OS data will be collected every 3 months ± 14 days) until death, withdrawal of informed consent, loss to follow-up, or study termination (whichever occurs first).
- Being tested
- Sorbitol + PD-1 inhibitor + SOX chemotherapy, PD-1 inhibitor + SOX chemotherapy
- Keywords
- sorbitol, tislelizumab, SOX, gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorbitol + PD-1 inhibitor + SOX chemotherapyDrug
PD-1 inhibitor + SOX chemotherapy. During the neoadjuvant treatment week, oral sorbitol 2-4g/ time, three times a day (with meals)
PD-1 inhibitor + SOX chemotherapyDrug
PD-1 inhibitor + SOX chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| sorbitol + aPD-1 + SOX | Experimental | Not described Receives: Drug: Sorbitol + PD-1 inhibitor + SOX chemotherapy |
| aPD-1 + SOX | Active comparator | Standard-of-Care Control: conventional neoadjuvant treatment regimen aPD-1 + SOX chemotherapy Receives: Drug: PD-1 inhibitor + SOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathological response
Pathological major response rate, including TRG 0/1
Measured: From end of preoperative treatment to the end of all treatment
ypN0 rate
The rate of no lymph node metastasis after treatment
Measured: From end of preoperative treatment to the end of all treatment
DFS rate
Disease-free survival rate
Measured: From enrollment to the end of treatment at 3 years
Secondary outcomes (4)
objective response rate
Measured: From end of preoperative treatment to the end of all treatment
R0 resection rate
Measured: From end of preoperative treatment to the end of all treatment
pathological complete response
Pathological complete response rate, No cancer cells remaining
Measured: From end of preoperative treatment to the end of all treatment
OS rates
overall survival rate
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Nov 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826079
- Sponsor's protocol ID
- UnionSor01
- Acronym
- SNCCTGC
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Oral Sorbitol to Enhance the Therapeutic Effect of Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06826079
- Acronym / sponsor ID
- SNCCTGC / UnionSor01
- Keywords
- sorbitol, tislelizumab, SOX, gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 13 Feb 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 goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol. The main questions it aims to answer are:
Does sorbitol enhance the therapeutic effect of immunotherapy and increase the major response rate in patients with locally advanced gastric cancer? Does sorbitol with neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) can improve the prognosis of patients with locally advanced gastric cancer?
Researchers will compare sorbitol to a standard-of-care treatment (aPD-1 + SOX chemotherapy) to see if sorbitol works to enhance the therapeutic effect (Add-on Effect) of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer.
Participants will:
Take sorbitol every day for 3 months in 3 treatment cycles Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first). After the end of treatment and safety follow-up, all subjects will be followed up for survival (OS data collected every 3 months ±14 days).
Detailed description
- Overall Design This study is an exploratory investigation on the efficacy of oral sorbitol combined with SOX chemotherapy and tislelizumab (PD-1 inhibitor) in the neoadjuvant treatment of advanced gastric/gastroesophageal junction adenocarcinoma based on the concepts of tumor metabolism and immunity. The study is divided into three phases: screening period, treatment period (neoadjuvant treatment, surgery and adjuvant treatment period), and follow-up period. A total of 86 subjects will be enrolled in this study and randomly divided into two groups. Group A: oral sorbitol + PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]); Group B: PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]) (see below for details).
- Screening Period: Subjects must undergo screening and evaluation within 14 days before the first dose to determine their eligibility for the study. The specific criteria are: histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with a clinical stage of cT3-4N+M0, and histological confirmation of mainly adenocarcinoma. Only Siewert type III and Siewert type II GEJ cancer patients who do not require combined thoracotomy are allowed to be enrolled. For patients who meet the inclusion and exclusion criteria, routine blood tests, imaging examinations, and Helicobacter pylori tests will be completed, and further molecular-level tests will be conducted, including MSI status, PD-1 expression CPS score, and EBER detection of pre-treatment biopsy pathological tissues. The enrolled subjects will be randomly divided into two groups. Group A: oral sorbitol + PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]); Group B: PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]).
- Treatment Period
The treatment period will include the following phases:
- Neoadjuvant treatment (before surgery) period: 3 cycles Group A (sorbitol diet group): PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]); During the neoadjuvant treatment period, oral sorbitol 2-4g per dose, three times a day (with meals). Group B (active control group): PD1 inhibitor + SOX for 3 cycles (1 cycle = every 3 weeks [Q3W]).
- Surgery: After evaluation of the efficacy of neoadjuvant treatment After neoadjuvant treatment, for subjects deemed eligible for surgery by the study, surgery should be performed within 2-6 weeks after the last dose of neoadjuvant treatment (including oral medication). For subjects who cannot undergo surgery, the subsequent treatment plan will be determined by the investigator based on the clinical situation. During the surgery, a small amount of pathological tissue should be taken and tested for AKR1B1/cGAS targets and sorbitol content.
- Adjuvant treatment (after surgery) period: 5 cycles Adjuvant treatment stage: Unblinding after surgery, adjuvant treatment can start 3 weeks to 12 weeks after surgery (beyond 12 weeks, the investigator can decide whether to continue using the experimental drug). Subjects in Group A and Group B will be grouped according to TRG grading. Subjects with TRG scores of 0-1 will continue the original treatment plan, while those with TRG scores greater than 2 will only receive SOX chemotherapy for up to 5 cycles, or until the investigator determines that the subject has lost clinical benefit, died, is intolerant to toxicity, withdraws informed consent, or for other reasons specified in the protocol (whichever occurs first).
- Follow-up Period: Including safety follow-up and survival follow-up. After the treatment ends, all subjects will be followed up. For subjects who discontinue treatment for reasons other than PD, follow-up will be conducted at the originally planned frequency until PD occurs, informed consent is withdrawn, or the subject is lost to follow-up (whichever occurs first). After the treatment ends and the safety follow-up is completed, all subjects will be followed up for survival (OS data will be collected every 3 months ± 14 days) until death, withdrawal of informed consent, loss to follow-up, or study termination (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sorbitol + aPD-1 + SOX | Experimental | Drug: Sorbitol + PD-1 inhibitor + SOX chemotherapy |
| aPD-1 + SOX | Active comparator | Drug: PD-1 inhibitor + SOX chemotherapyStandard-of-Care Control: conventional neoadjuvant treatment regimen aPD-1 + SOX chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18 years ≤ age ≤ 70 years, gender not restricted.
- Written informed consent obtained from the patient.
- Histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with clinical stage cT3-4N+M0, and histological examination confirming mainly adenocarcinoma. Only Siewert type III GEJ cancer and Siewert type II GEJ cancer patients who do not require combined thoracotomy are eligible for inclusion.
- ECOG PS score of 0-1.
- Normal major organ function, meeting the following criteria:
Key exclusion criteria (17 listed)
- Presence of distant organ metastasis and peritoneal disseminated metastasis.
- Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis [excluding diverticular disease], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]), except for patients with vitiligo or alopecia, provided that they have celiac disease that can be controlled through diet after consultation with the study doctor.
- Other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.
- Patients preparing for or having previously undergone organ or bone marrow transplantation.
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV/HCV, pneumonia, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD, severe chronic gastrointestinal diseases with diarrhea, or conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or affect the ability of the subject to provide written informed consent.
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 |
|---|---|---|
| Sorbitol + PD-1 inhibitor + SOX chemotherapyPD-1 inhibitor + SOX chemotherapy. During the neoadjuvant treatment week, oral sorbitol 2-4g/ time, three times a day (with meals) | Drug | sorbitol + aPD-1 + SOX |
| PD-1 inhibitor + SOX chemotherapyPD-1 inhibitor + SOX chemotherapy | Drug | aPD-1 + SOX |
Primary outcome
major pathological response
Time frame: From end of preoperative treatment to the end of all treatment
Pathological major response rate, including TRG 0/1
ypN0 rate
Time frame: From end of preoperative treatment to the end of all treatment
The rate of no lymph node metastasis after treatment
DFS rate
Time frame: From enrollment to the end of treatment at 3 years
Disease-free survival rate
4 secondary outcomes
objective response rate
Time frame: From end of preoperative treatment to the end of all treatment
R0 resection rate
Time frame: From end of preoperative treatment to the end of all treatment
pathological complete response
Time frame: From end of preoperative treatment to the end of all treatment
OS rates
Time frame: From enrollment to the end of treatment at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 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.
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 Sorbitol + PD-1 inhibitor + SOX chemotherapy and PD-1 inhibitor + SOX chemotherapy in people with Gastric Junction Adenocarcinoma and Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 13 inclusion and 17 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 18 Aug 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?
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 Yao Lin, Dr. (86+13294158510, linyaomt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major pathological response (time frame: From end of preoperative treatment to the end of all treatment). The study lists 3 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 18 Aug 2026.