Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])Phase 3NCT06925243
Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 3 study testing Neoadjuvant apatinib combined with sintilimab and perioperative SOX and Neoadjuvant sintilimab combined with perioperative SOX in people with Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]) and Neoadjuvant Therapy, run by Zuoyi Jiao at 4 sites in China.
Trial summary
This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer/gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Neoadjuvant Therapy, Adjuvant Chemotherapy
- What is being tested?
- Neoadjuvant apatinib combined with sintilimab and perioperative SOX and Neoadjuvant sintilimab combined with perioperative SOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 4 sitesChina
- Study dates
- 15 Apr 2025to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type of Participant and Disease Characteristics
- Patients must have a pathologically confirmed diagnosis of HER-2 negative tumor and intestinal type gastric or gastroesophageal junction adenocarcinoma according to Lauren's histological subtypes.
- Patients must have previously untreated locally advanced gastric or gastroesophageal junction adenocarcinoma (stage cT2 to cT4), with lymph nodes ranging from N0 to N3 and no evidence of metastatic disease (M0).
- Patients with Siewert type 2 or 3 tumors are eligible. Enrollment of participants with Siewert type 1 tumors will be limited to those for whom the planned treatment is perioperative chemotherapy and resection.
- Demographics
- Male or female subjects must be between the ages of ≥ 18 and ≤ 75 years at the time of signing the informed consent.
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- Expected Survival: The expected survival time must be ≥ 12 weeks.
- Performance Status: Subjects must have an ECOG performance status of 0 or 1.
- Male Contraception: Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception from Day 1 through 120 days after receipt of the final dose of the investigational product. It is strongly recommended for the female partner of a male subject to also use an effective method of contraception throughout this period.
- Female subjects of childbearing potential must be willing to use adequate contraception methods throughout the study and for 120 days after the last dose of the study drug. The decision to discontinue contraception after this time point should be discussed with the attending physician. Periodic abstinence, contraceptive rhythm methods, and withdrawal are not acceptable forms of contraception.
- Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.
- Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.
- ii.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.
- If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.
- Organ Function
- Blood Routine (no blood transfusion within 14 days): WBC ≥ 3.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L; HGB ≥ 80 g/L.
- Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT/AST levels ≤ 2.5 × ULN.
- Renal Function: Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL/min for those with Cr > 1.5 × ULN.
- Coagulation Function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.
- Cardiac Function: Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.
- Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.
- Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.
- iv.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.
- If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.
- Informed Consent All subjects must provide written informed consent to participate in the study.
- Other Inclusions
- Prior Treatment: Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
- Be willing to provide tissue and blood sample from a tumor lesion at baseline and at time of surgery
Who cannot join
- Medical Conditions
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years (except for cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ that has undergone potentially curative therapy).
- Has an active infection requiring systemic therapy.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years. (NOTE: Subjects with vitiligo, alopecia, Grave's disease, Type I diabetes mellitus, hypothyroidism (e.g., following Hashimoto's syndrome) only requiring hormone replacement on a stable dose (without adjustment in the first 4 weeks of study treatment), psoriasis or eczema not requiring systemic treatment (within the past 2 years), or conditions not expected to recur in the absence of an external trigger are not excluded.)
- Has any complications requiring systemic treatment with corticosteroids such as prednisone (> 10mg/day) or other immunosuppressive medications within 14 days prior to the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
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- History of primary immunodeficiency.
- Has received a live vaccine or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin, or immunotherapy) within 30 days prior to the first dose of study treatment.
- Has a known history of active tuberculosis.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Has a known severe allergy or hypersensitivity to sintilimab or apatinib or any of the study chemotherapy agents and/or to any of their excipients.
- Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:
- Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 480 ms), grade III or IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50.0% as determined by ultrasonic cardiography.
- Cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombotic, embolic, or ischemic events.
- Prior/Concomitant Therapy
- Subjects who have already enrolled in another clinical study, unless it is an observational, non-interventional clinical study, or they are in the follow-up period for an interventional study.
- Subjects who have received any systemic or curative anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy.
- Subjects who have previously received any anti-PD-1, anti-PD-L1 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.).
- Other exclusion criteria
- Confirmed HER-2 positive tumor will be excluded.
- Patients could not provide tumor samples and blood samples.
- Pregnant or lactating patients, as well as patients with childbearing potential who plan to be pregnant within 5 months after the study; Women of childbearing should receive a blood pregnancy test within 7 days before the study.
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
First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Da Zhao, +86-13893230123, zhaodamail@163.com
Da Zhao
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Xiaoning Zhao, +86-18993113172, 19239234@qq.com
Xiaoning Zhao
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000
Bo Long, +86 130 0878 1208, longbo_107@163.com
Bo Long
- Recruiting
The Gastrointestinal Surgery Department, Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, Gansu, 730000
Dengwen Wei, +86-13919916710, dengwen002@163.com
Dengwen Wei
About this study
Official title: Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label, Randomized Controlled Phase III Study
This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer/gastroesophageal junction adenocarcinoma. The primary questions include:
- Whether the complete remission rate (pCR) of the apatinib combined with sintilimab and SOX regimen is higher than that of the sintilimab combined with SOX regimen.
- The safety of the apatinib combined with sintilimab and SOX regimen.
Read more
Participants will be divided into:
- Experimental Group: Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles.
- Control Group: Participants will receive treatment with the sintilimab combined with the SOX regimen.
This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Surgery is scheduled four weeks after the last neoadjuvant therapy (NAT) cycle. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks.
- Conditions
- Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Neoadjuvant Therapy, Adjuvant Chemotherapy, pCR Rate, MPR, ORR,OS,PFS
- Being tested
- Neoadjuvant apatinib combined with sintilimab and perioperative SOX, Neoadjuvant sintilimab combined with perioperative SOX
- Keywords
- apatinib, sintilimab, SOX, Neoadjuvant therapy, gastric cancer, intestinal type
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant apatinib combined with sintilimab and perioperative SOXDrug
Sintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA < 1.25 m², 40 mg bid, 1.25 m² ≤ BSA < 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid) Apatinib: 250mg, po, day1-21, for 3 cycles preoperatively
Neoadjuvant sintilimab combined with perioperative SOXDrug
Sintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA < 1.25 m², 40 mg bid, 1.25 m² ≤ BSA < 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid)
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant apatinib combined with sintilimab and perioperative SOX group | Experimental | Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles. This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks. Receives: Drug: Neoadjuvant apatinib combined with sintilimab and perioperative SOX |
| Neoadjuvant sintilimab combined with perioperative SOX group | Active comparator | Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks. Receives: Drug: Neoadjuvant sintilimab combined with perioperative SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Pathological Complete Response rate (pCR) refers to the proportion of cases in which no active cancer cells are detected in the surgically resected tumor tissue after neoadjuvant therapy, as assessed using the Becker TRG grading system.
Measured: Enrollment to surgical treatment takes about 4 months.
Secondary outcomes (12)
Major pathological response (MPR) rate
Major Pathological Response (MPR) rate refers to the proportion of patients who, after receiving neoadjuvant therapy, are assessed using the Becker TRG grading system and have less than 10% residual viable cancer cells in the surgically resected tumor tissue.
Measured: Enrollment to surgical treatment takes about 4 months.
Objective response rate (ORR)
The Objective Response Rate (ORR) is a widely used efficacy measure in clinical trials, especially in oncology, to assess the objective changes in tumors in response to treatment. It represents the proportion of patients whose tumors have achieved either a Complete Response (CR) or a Partial Response (PR). The assessment of ORR is typically based on the internationally standardized criteria for evaluating solid tumor responses, known as RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, version 1.1).
Measured: From enrollment to preoperative imaging assessment, it takes approximately 4 months.
3-year survival rate (3-year OS rate)
The 3-year survival rate (3-year OS rate) is the percentage of patients who survive 3 years after enrollment.
Measured: From the point of enrollment to the end of the 3-year follow-up period.
Adverse Event
For the classification and grading of Adverse Events (AEs), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 is generally used as the standard.
Measured: From enrollment to the completion or discontinuation of treatment, an estimated duration of eight months is expected.
Disease control rate (DCR)
DCR is the percentage of patients with measurable disease at baseline who experience CR, PR, or SD, as determined by BICR using RECIST v1.1 guidelines.
Measured: From enrollment to preoperative imaging assessment, it takes approximately 4 months.
3-year event-free survival rate (3-year EFS rate).
3-year EFS rate is defined as the proportion of patients who remain free from disease recurrence, progression, or death over a three-year period, without experiencing any predefined adverse events.
Measured: From the point of enrollment to the end of the 3-year follow-up period.
R0 resection rate
The R0 resection rate is defined as the proportion of patients in whom no cancer cells are detected at the surgical margins under microscopic examination, indicating complete removal of the tumor with no visible residual cancer, both macroscopically and microscopically.
Measured: Enrollment to surgical treatment takes about 4 months.
Downstaging rates of T, N, TNM stages.
The tumor downstage rate represents the percentage of patients whose overall ypTNM, T, or N stage has decreased from their baseline cTNM, cT, or cN stage. Tumor staging was assessed using baseline cTNM and postoperative ypTNM evaluations according to the 8th edition of the AJCC Gastric Cancer Staging Manual.
Measured: Enrollment to preoperative imaging assessment takes about 4 months.
Surgery-related complications
Surgery-related complications are defined as any complications occurring within 30 days following surgery, classified according to the Clavien-Dindo Classification of Surgical Complications. These complications include, but are not limited to, vomiting, fever, incision infection, post-operative pneumonia, anastomotic hemorrhage or leakage, chylous leakage, pneumonia, intestinal obstruction, and other related issues.
Measured: Enrollment to surgical treatment takes about 4 months.
Programmed death-ligand 1 combined positive score (PD-L1 CPS)
PD-L1 expression acts as a predictive biomarker for assessing treatment efficacy, encompassing metrics such as the pathologic complete response rate (pCR rate), major pathologic response rate (MPR rate), and both the 3-year overall survival rate (OS rate) and 3-year Event-Free Survival (EFS) rate.
Measured: After enrollment, the measurements were completed.
Microsatellite instability (MSI) status
Microsatellite instability status acts as a predictive biomarker for assessing treatment efficacy, encompassing metrics such as the pathologic complete response rate (pCR rate), major pathologic response rate (MPR rate), and both the 3-year overall survival rate (OS rate) and 3-year Event-Free Survival (EFS) rate.
Measured: After enrollment, the measurements were completed.
The ratio of NG2+/CD31
The ratio of NG2+/CD31 acts as a predictive biomarker for assessing treatment efficacy, encompassing metrics such as the pathologic complete response rate (pCR rate), major pathologic response rate (MPR rate), and both the 3-year overall survival rate (OS rate) and 3-year Event-Free Survival (EFS) rate.
Measured: Enrollment to surgical treatment takes about 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start15 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 682 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuoyi Jiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zuoyi Jiao, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925243
- Sponsor's protocol ID
- LanzhouU2H-2025A-120
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 22 Apr 2025
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label, Randomized Controlled Phase III Study
- ClinicalTrials.gov ID
- NCT06925243
- Acronym / sponsor ID
- LanzhouU2H-2025A-120
- Conditions
- Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Neoadjuvant Therapy, Adjuvant Chemotherapy, pCR Rate, MPR, ORR,OS,PFS
- Keywords
- apatinib, sintilimab, SOX, Neoadjuvant therapy, gastric cancer, intestinal type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 682 participants (estimated)
- Lead sponsor
- Zuoyi JiaoUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Apr 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.
This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer/gastroesophageal junction adenocarcinoma. The primary questions include:
- Whether the complete remission rate (pCR) of the apatinib combined with sintilimab and SOX regimen is higher than that of the sintilimab combined with SOX regimen.
- The safety of the apatinib combined with sintilimab and SOX regimen.
Participants will be divided into:
- Experimental Group: Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles.
- Control Group: Participants will receive treatment with the sintilimab combined with the SOX regimen.
This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Surgery is scheduled four weeks after the last neoadjuvant therapy (NAT) cycle. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant apatinib combined with sintilimab and perioperative SOX group | Experimental | Drug: Neoadjuvant apatinib combined with sintilimab and perioperative SOXParticipants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles. This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks. |
| Neoadjuvant sintilimab combined with perioperative SOX group | Active comparator | Drug: Neoadjuvant sintilimab combined with perioperative SOXParticipants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Type of Participant and Disease Characteristics
- Demographics
- ii.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.
- Organ Function
- iv.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.
Key exclusion criteria (22 listed)
- Medical Conditions
- Prior/Concomitant Therapy
- Other exclusion criteria
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 apatinib combined with sintilimab and perioperative SOXSintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA < 1.25 m², 40 mg bid, 1.25 m² ≤ BSA < 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid) Apatinib: 250mg, po, day1-21, for 3 cycles preoperatively | Drug | Neoadjuvant apatinib combined with sintilimab and perioperative SOX group |
| Neoadjuvant sintilimab combined with perioperative SOXSintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA < 1.25 m², 40 mg bid, 1.25 m² ≤ BSA < 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid) | Drug | Neoadjuvant sintilimab combined with perioperative SOX group |
Primary outcome
Pathological complete response (pCR) rate
Time frame: Enrollment to surgical treatment takes about 4 months.
Pathological Complete Response rate (pCR) refers to the proportion of cases in which no active cancer cells are detected in the surgically resected tumor tissue after neoadjuvant therapy, as assessed using the Becker TRG grading system.
12 secondary outcomes
Major pathological response (MPR) rate
Time frame: Enrollment to surgical treatment takes about 4 months.
Objective response rate (ORR)
Time frame: From enrollment to preoperative imaging assessment, it takes approximately 4 months.
3-year survival rate (3-year OS rate)
Time frame: From the point of enrollment to the end of the 3-year follow-up period.
Adverse Event
Time frame: From enrollment to the completion or discontinuation of treatment, an estimated duration of eight months is expected.
Disease control rate (DCR)
Time frame: From enrollment to preoperative imaging assessment, it takes approximately 4 months.
3-year event-free survival rate (3-year EFS rate).
Time frame: From the point of enrollment to the end of the 3-year follow-up period.
R0 resection rate
Time frame: Enrollment to surgical treatment takes about 4 months.
Downstaging rates of T, N, TNM stages.
Time frame: Enrollment to preoperative imaging assessment takes about 4 months.
Surgery-related complications
Time frame: Enrollment to surgical treatment takes about 4 months.
Programmed death-ligand 1 combined positive score (PD-L1 CPS)
Time frame: After enrollment, the measurements were completed.
Microsatellite instability (MSI) status
Time frame: After enrollment, the measurements were completed.
The ratio of NG2+/CD31
Time frame: Enrollment to surgical treatment takes about 4 months.
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 22 Apr 2025.
- Individual participant dataSharing planned: No
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 3 study testing Neoadjuvant apatinib combined with sintilimab and perioperative SOX and Neoadjuvant sintilimab combined with perioperative SOX in people with Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]) and Neoadjuvant Therapy, run by Zuoyi Jiao 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 31 inclusion and 22 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 22 Apr 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Bo Long (+86 130 0878 1208, longbo_107@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: Enrollment to surgical treatment takes about 4 months.). 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 22 Apr 2025.