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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Neo-Sequence 2:NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC

Neo-Sequence 2:Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer

Neo-Sequence 2:NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC (NCT06371586) is a Phase 2 interventional studying Gastric Cancer and Diffuse Type Carcinoma, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 67 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastric Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy; 2. Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition); 3. Has not received any anti-tumor treatment for gastric cancer yet; 4. Age range from 18 to 75 years old; 5. ECOG score 0-1 points; 6. Liver and kidney function and blood routine meet the following conditions: Neutrophils\>1.5G/L, Hb\>90g/L, PLT\>100G/L; ALT and AST\<2.5ULN; TBIL\<1.5 ULN; Cr\<1.0ULN; 7. Left ventricular ejection fraction\>60%; 8. Good compliance and ability to accept long-term follow-up; 9. Sign willing to sign a consent form. Who Should NOT Join This Trial: 1. Gastrointestinal obstruction or recurrent bleeding cannot be controlled; 2. Those who cannot swallow pills; 3. Diagnose weakened immune system or active autoimmune conditions (where your immune system attacks your own body)s, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years; 4. Interstitial pneumonia; 5. Moderate to severe cirrhosis caused by any reason; 6. Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases; 7. Active infections that require systemic treatment; 8. Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ; 9. Internal medicine diseases that do not meet the chemotherapy criteria at the same time; 10. Pregnant and lactating patients; 11. Individuals with a history of mental illness and poor compliance. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy; 2. Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition); 3. Has not received any anti-tumor treatment for gastric cancer yet; 4. Age range from 18 to 75 years old; 5. ECOG score 0-1 points; 6. Liver and kidney function and blood routine meet the following conditions: Neutrophils\>1.5G/L, Hb\>90g/L, PLT\>100G/L; ALT and AST\<2.5ULN; TBIL\<1.5 ULN; Cr\<1.0ULN; 7. Left ventricular ejection fraction\>60%; 8. Good compliance and ability to accept long-term follow-up; 9. Sign informed consent. Exclusion Criteria: 1. Gastrointestinal obstruction or recurrent bleeding cannot be controlled; 2. Those who cannot swallow pills; 3. Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years; 4. Interstitial pneumonia; 5. Moderate to severe cirrhosis caused by any reason; 6. Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases; 7. Active infections that require systemic treatment; 8. Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ; 9. Internal medicine diseases that do not meet the chemotherapy criteria at the same time; 10. Pregnant and lactating patients; 11. Individuals with a history of mental illness and poor compliance.

Treatments Being Tested

DRUG

Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy

Albumin paclitaxel+SOX+BEV bi weekly neoadjuvant therapy for 6 cycles, with PD-1 monoclonal antibody therapy interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the two-week regimen of albumin paclitaxel+bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or maintenance medication treatment will be determined based on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative and pathological results of the surgery. Those who fail to evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch to a second-line systemic treatment plan.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cancer hospital,Chinese acadamy of medical sciences
Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06371586), the sponsor (Cancer Institute and Hospital, Chinese Academy of Medical Sciences), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06371586 clinical trial studying?

The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06371586?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06371586?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06371586. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06371586. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.