Gastric CancerPhase 2NCT06371586
Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC
A Phase 2 study testing Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy in people with Gastric Cancer and Diffuse Type Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Diffuse Type Carcinoma
- What is being tested?
- Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Mar 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
- 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);
- Has not received any anti-tumor treatment for gastric cancer yet;
- Age range from 18 to 75 years old;
- ECOG score 0-1 points;
- Liver and kidney function and blood routine meet the following conditions:
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- Neutrophils>1.5G/L, Hb>90g/L, PLT>100G/L; ALT and AST<2.5ULN; TBIL<1.5 ULN; Cr<1.0ULN;
- Left ventricular ejection fraction>60%;
- Good compliance and ability to accept long-term follow-up;
- Sign informed consent.
Who cannot join
- Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
- Those who cannot swallow pills;
- Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
- Interstitial pneumonia;
- Moderate to severe cirrhosis caused by any reason;
- Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
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- Active infections that require systemic treatment;
- Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
- Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
- Pregnant and lactating patients;
- Individuals with a history of mental illness and poor compliance.
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
Cancer hospital，Chinese acadamy of medical sciences
Beijing
Chunxia Du, 87787121, retinadcx@vip.163.com
About this study
Official title: Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer
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.
Read the detailed description
The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was 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 dual cycle regimen ofAlbumin 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.
- Conditions
- Gastric Cancer, Diffuse Type Carcinoma
- Being tested
- Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapyDrug
Also called PSBP
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy Receives: Drug: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate
No residual cancer cells
Measured: 3 year
Secondary outcomes (4)
EFS
event free survival
Measured: 3 year
OS
overall survival
Measured: 3 year
R0
Negative margin of incision
Measured: 3 year
Safety (adverse events) and surgical complications
Chemotherapy side effects and surgical safety
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunxia Du, MD, Study chair, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371586
- Sponsor's protocol ID
- NCC4537
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer
- ClinicalTrials.gov ID
- NCT06371586
- Acronym / sponsor ID
- NCC4537
- Conditions
- Gastric Cancer, Diffuse Type Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 17 Apr 2024 (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 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.
Detailed description
The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was 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 dual cycle regimen ofAlbumin 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapyNeoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
- 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);
- Has not received any anti-tumor treatment for gastric cancer yet;
- Age range from 18 to 75 years old;
- ECOG score 0-1 points;
Key exclusion criteria (11 listed)
- Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
- Those who cannot swallow pills;
- Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
- Interstitial pneumonia;
- Moderate to severe cirrhosis caused by any reason;
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 |
|---|---|---|
| Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapyAlso: PSBPAlbumin 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. | Drug | Experimental arm |
Primary outcome
Pathological response rate
Time frame: 3 year
No residual cancer cells
4 secondary outcomes
EFS
Time frame: 3 year
OS
Time frame: 3 year
R0
Time frame: 3 year
Safety (adverse events) and surgical complications
Time frame: 3 year
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 17 Apr 2024.
- 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.
Chunxia Du, MD study chair
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy in people with Gastric Cancer and Diffuse Type Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 10 inclusion and 11 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 17 Apr 2024. 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 Chunxia Du, MD (87787121, retinadcx@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response rate (time frame: 3 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 17 Apr 2024.