Gastric CancerNCT05540145
Neo-Sequence 1: Neoadjuvant Chemotherapy With or Without Antiangiogenesis and Sequential Immunotherapy for HER2-negative MMR-proficient Locally Advanced Gastric or Gastroesophageal Adenocarcinoma
An observational study of Gastric Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-institution, prospective phase II trial designed to evaluate the efficacy of neoadjuvant chemotherapy and sequential immunotherapy in patients with locally advanced esophagogastric junction and gastric adenocarcinoma. Patients with Her-2 positive or dMMR tumors will be excluded from the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibody
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with endoscopically biopsy-proven Her-2(-), pMMR gastric cancer will receive preoperative neoadjuvant therapy.
Who may be able to join
- Be willing and able to provide written (signed) informed consent;
- Age ≥ 18 years and ≤75 years.
- Has a pathologic diagnosis of gastroesophageal or gastric adenocarcinoma, mucinous adenocarcinoma or signet ring cell carcinoma.
- Imaging (CT/ultrasonography of cervical lymph nodes and supraclavicular lymph nodes/ endoscopy and endoscopic ultrasound) confirmed at the stage of cT3/4a NanyM0(AJCC 8th).
- Confirmed by immunohistochemistry (IHC) staining or genetic and transcriptional profiling detection to meet all of the following conditions:
- Her-2-negative was defined as IHC -, IHC 1+ or IHC 2+ and FISH negative;
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- Mismatch repair-proficient (pMMR).
- The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
- The main organ function meets the following criteria within 7 days before treatment:
- Hemoglobin (Hb) level ≥9.0 g/dl.
- Neutrophil count (ANC)≥1.5×10^9/L.
- Platelet (PLT) ≥100×10^9/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN.
- Serum creatinine (Cr) level ≤1.0×ULN and creatinine clearance ≥60 ml/min.
- Total bilirubin(TBIL) level ≤1.5×ULN.
Who cannot join
- Confirmed at stage IV (AJCC 8th) or unresectable by investigator before enrolling.
- Patienta have had prior chemotherapy, targeted small molecule therapy, or radiation therapy for the current diagnosis of EGJ cancer or gastric cancer.
- Patients are allergic to study medication and its ingredients.
- Patients have experienced or currently have other malignancies within 5 years.
- Patients have an active infection requiring systemic therapy.
- Women who are pregnant, breast-feeding or planning to become pregnant during treatment or within 6 months after treatment ends.
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- Patients have a history of psychotropic substance abuse and are unable to quit or have a mental disorder.
- Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.
- Diagnosis of immunodeficiency or active autoimmune disease, receiving or being treated with immunomodulators, systemic steroids or immunosuppressive drugs in the past two years.
- Patients with gastrointestinal obstruction or uncontrolled bleeding undergo emergency surgery.
- The proportion of other components in the pathology (such as squamous cell carcinoma, neuroendocrine carcinoma, etc.) exceeds 10%
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, 100021
About this study
Official title: Neo-Sequence 1: Phase 2 Study of Neoadjuvant Chemotherapy With or Without Antiangiogenesis and Sequential Immunotherapy for HER2-negative MMR-proficient Locally Advanced Gastric or Gastroesophageal Adenocarcinoma
This is a single-institution, prospective phase II trial designed to evaluate the efficacy of neoadjuvant chemotherapy and sequential immunotherapy in patients with locally advanced esophagogastric junction and gastric adenocarcinoma. Patients with Her-2 positive or dMMR tumors will be excluded from the study. Six cycles of nab-paclitaxel, oxaliplatin and S-1 with or without bevacizumab, followed by three circles of nab-paclitaxel, bevacizumab, with or without S-1 combined with two cycles of PD-1 monoclonal antibody, will be administered as neoadjuvant therapy. Patients will receive different adjuvant treatments depending on the degrees of surgical radicality and the pathological reactions of tumors.
- Conditions
- Gastric Cancer
- Being tested
- SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibody
- Keywords
- Neoadjuvant Chemotherapy, Immunotherapy, safety, Efficacy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibodyDrug
Drug: Paclitaxel(albumin-bound) 130mg/m2, ivgtt, D1, Q2w Drug: Oxaliplatin 70 mg/m2, ivgtt, D1, q2w Drug: S-1 40mg (body surface area < 1.25m2), bid, D1-8, Q2w 50mg (body surface area >1.25m2, <1.5 m2), bid, D1-8, Q2w 60mg (body surface area >1.5m2), bid, D1-8, Q2w Drug: Bevacizumab, 5mg/kg, ivgtt, D1, Q14d Drug: PD-1 antibody, 200mg, ivgtt, D1, Q21d Patients with Her-2 negative, MMR-proficient locally advanced esophagogastric junction or gastric adenocarcinoma will receive 6 cycles of neoadjuvant chemotherapy with or without antiangiogenesis. After comprehensive evaluations, patients who respond to chemotherapy will further receive 2 cycles of PD-1 antibody comibed with antiangiogenesis and chemotherapy as neoadjuvant therapy.
Drug: Pembrolizumab or sintilimab, 100~200mg, ivgtt, D1, Q3w. Patients will make the final decision of PD -1 antibody according to their economic condition.
| Study group | Role | What they receive |
|---|---|---|
| SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibody | SOX: Oxaliplatin+S-1 Receives: Drug: SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
The time from recruitment to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause.
Measured: From the recruitment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes (4)
Major pathological response
It is defined as residual tumors less than 10% after neoadjuvant systemic therapy according to Mandard grade.
Measured: From the date of recruitment to 3 months after all treatment ends
Overall survival(OS)
The time from recruitment to the date of death for any reason or the date of last follow-up
Measured: From the date of recruitment to the date of death from any cause or the date of last follow-up, assessed up to 36 months
R0 resection rate
Rate of microscopically margin-negative resection
Measured: From the date of recruitment to 3 months after all treatment ends
Adverse events
Adverse events (AEs) of neoadjuvant and adjuvant systemic therapy will be graded and documented according to NCI-CTCAE v5.0 and immune-related Adverse Event, irAE from the beginning of treatment to 3 months since the last dosage of treatment. Documentary will include severity, lasting period and occurrence time. Surgery complications will also be documented.
Measured: From the date of recruitment to 3 months after all treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 May 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Bing Zhao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540145
- Sponsor's protocol ID
- 21/489-3160
- Status last verified
- Apr 2024
- First submitted
- 12 Sep 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-Sequence 1: Phase 2 Study of Neoadjuvant Chemotherapy With or Without Antiangiogenesis and Sequential Immunotherapy for HER2-negative MMR-proficient Locally Advanced Gastric or Gastroesophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05540145
- Acronym / sponsor ID
- 21/489-3160
- Conditions
- Gastric Cancer
- Keywords
- Neoadjuvant Chemotherapy, Immunotherapy, safety, Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Sep 2022 (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 is a single-institution, prospective phase II trial designed to evaluate the efficacy of neoadjuvant chemotherapy and sequential immunotherapy in patients with locally advanced esophagogastric junction and gastric adenocarcinoma. Patients with Her-2 positive or dMMR tumors will be excluded from the study. Six cycles of nab-paclitaxel, oxaliplatin and S-1 with or without bevacizumab, followed by three circles of nab-paclitaxel, bevacizumab, with or without S-1 combined with two cycles of PD-1 monoclonal antibody, will be administered as neoadjuvant therapy. Patients will receive different adjuvant treatments depending on the degrees of surgical radicality and the pathological reactions of tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibody | – | Drug: SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibodySOX: Oxaliplatin+S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with endoscopically biopsy-proven Her-2(-), pMMR gastric cancer will receive preoperative neoadjuvant therapy.
Key inclusion criteria (15 listed)
- Be willing and able to provide written (signed) informed consent;
- Age ≥ 18 years and ≤75 years.
- Has a pathologic diagnosis of gastroesophageal or gastric adenocarcinoma, mucinous adenocarcinoma or signet ring cell carcinoma.
- Imaging (CT/ultrasonography of cervical lymph nodes and supraclavicular lymph nodes/ endoscopy and endoscopic ultrasound) confirmed at the stage of cT3/4a NanyM0(AJCC 8th).
- Confirmed by immunohistochemistry (IHC) staining or genetic and transcriptional profiling detection to meet all of the following conditions:
Key exclusion criteria (11 listed)
- Confirmed at stage IV (AJCC 8th) or unresectable by investigator before enrolling.
- Patienta have had prior chemotherapy, targeted small molecule therapy, or radiation therapy for the current diagnosis of EGJ cancer or gastric cancer.
- Patients are allergic to study medication and its ingredients.
- Patients have experienced or currently have other malignancies within 5 years.
- Patients have an active infection requiring systemic therapy.
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 |
|---|---|---|
| SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibodyDrug: Paclitaxel(albumin-bound) 130mg/m2, ivgtt, D1, Q2w Drug: Oxaliplatin 70 mg/m2, ivgtt, D1, q2w Drug: S-1 40mg (body surface area < 1.25m2), bid, D1-8, Q2w 50mg (body surface area >1.25m2, <1.5 m2), bid, D1-8, Q2w 60mg (body surface area >1.5m2), bid, D1-8, Q2w Drug: Bevacizumab, 5mg/kg, ivgtt, D1, Q14d Drug: PD-1 antibody, 200mg, ivgtt, D1, Q21d Patients with Her-2 negative, MMR-proficient locally advanced esophagogastric junction or gastric adenocarcinoma will receive 6 cycles of neoadjuvant chemotherapy with or without antiangiogenesis. After comprehensive evaluations, patients who respond to chemotherapy will further receive 2 cycles of PD-1 antibody comibed with antiangiogenesis and chemotherapy as neoadjuvant therapy. Drug: Pembrolizumab or sintilimab, 100~200mg, ivgtt, D1, Q3w. Patients will make the final decision of PD -1 antibody according to their economic condition. | Drug | SOX plus Paclitaxel with or without antiangiogenesis followed by PD-1 antibody |
Primary outcome
Event-free survival (EFS)
Time frame: From the recruitment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
The time from recruitment to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause.
4 secondary outcomes
Major pathological response
Time frame: From the date of recruitment to 3 months after all treatment ends
Overall survival(OS)
Time frame: From the date of recruitment to the date of death from any cause or the date of last follow-up, assessed up to 36 months
R0 resection rate
Time frame: From the date of recruitment to 3 months after all treatment ends
Adverse events
Time frame: From the date of recruitment to 3 months after all treatment ends
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 16 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, 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 15 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: finished, as of the sponsor's last update on 16 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.
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?
Event-free survival (EFS) (time frame: From the recruitment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years). 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 16 Apr 2024.