HER2-positivePhase 2NCT05218148
SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma
A Phase 2 study testing sintilimab, Trastuzumab and S-1 plus oxaliplatin in people with HER2-positive and Locally Advanced Solid Tumor, run by Aiping Zhou at 1 site in China.
Trial summary
The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer；For HER2-positive locally advanced gastric cancer, some phase II studies have shown that chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive, Locally Advanced Solid Tumor, Immunotherapy
- What is being tested?
- sintilimab, Trastuzumab and S-1 plus oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Dec 2025
- Phase
- Phase 2
- 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
Who may be able to join
- Sign the informed consent form.
- Locally advanced adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III) confirmed by pathology or cytology.
- The definition of a positive HER2 test result is as follows: IHC detects HER2 3+ or IHC detects HER2 2+ and FISH is positive.
- Clinically, based on chest, abdomen and pelvic CT, gastroscopy, endoscopic ultrasonography, gastrointestinal contrast, ordinary ultrasound, or laparoscopy if possible, it is judged as T3-4a N+ or T4bN any gastric cancer or gastroesophageal junction cancer (refer to AJCC Article Version 8 in stages).
- Patients have not received chemotherapy and/or immunotherapy and/or trastuzumab treatment and/or radiotherapy in the past.
- Age 18-75 years old.
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- The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1, and there was no deterioration within 2 weeks before the first administration of the study drug.
- Good organ function:
- Blood routine: hemoglobin ≥90g/L, white blood cell ≥3.0×109/L, neutrophil ≥1.5×109/L, platelet ≥100×109/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥60ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL.
Who cannot join
- The pathology is other types besides adenocarcinoma, such as squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma and so on.
- Have received chemotherapy and/or radiotherapy in the past.
- Have received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies and other immunotherapy in the past.
- Have received any anti-HER2 therapy in the past.
- Intra-abdominal dissemination or distant metastasis (M1).
- Clinically significant ascites.
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- Known to have allergic reactions to oxaliplatin and any ingredients or excipients of Tiggio.
- Known to have allergic reactions to any ingredients or excipients of Sintilimab and Trastuzumab.
- Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
Official title: Phase II Clinical Study of Oxaliplatin Plus S-1 (SOX) Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of Locally Advanced HER2-positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer；For HER2-positive locally advanced gastric cancer, some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological remission rate;This prospective phase II clinical trial was designed, using SOX combined with sintilimab and trastuzumab to treat HER2 positive locally advanced gastric or gastroesophageal junction adenocarcinoma patients.
Read the detailed description
This phase II trial is a single-arm and single-center clinical study. Neoadjuvant chemotherapy is a standard treatment for locally advanced gastric cancer. The SOX regimen has became the standard perioperative chemotherapy regimen for locally advanced gastric cancer. For HER2-positive locally advanced gastric cancer, the neoadjuvant treatment is still based on chemotherapy alone. Some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological response. But it has not yet become a standard treatment strategy.
In the field of gastric cancer, checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer. PD-1 monoclonal antibody (Sintilimab) + trastuzumab + chemotherapy (SOX regimen ) may be an ideal perioperative treatment for HER2-positive locally advanced gastric cancer.
- Conditions
- HER2-positive, Locally Advanced Solid Tumor, Immunotherapy, Sintilimab, S-1, Oxaliplatin
- Being tested
- sintilimab, Trastuzumab, S-1 plus oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimabDrug
Sintilimab 200mg was administered as a 30-60 min intravenous (IV) infusion every 3 weeks.3 cycles before surgery and 5 cycles after surgery.
TrastuzumabDrug
Trastuzumab was 8mg/kg for the first time, and 6mg/kg for the follow-up. 3 cycles before surgery and 5 cycles after surgery.
S-1 plus oxaliplatinDrug
Oxaliplatin 130 mg/m2 was administered IV every 3 weeks. S-1 was given orally twice daily for the first 2 weeks of each 3-week cycle. The S-1 dose was 40 mg for body surface area (BSA) < 1.25 m2, 50 mg for BSA 1.25 to <1.5 m2 and 60 mg for BSA ≥1.5 m2.
Body surface area \<1.25m2: Tegio 40mg bid day 1 ~ 14; Body surface area 1.25 ~ \<1.5m2: Tegio 50mg bid day 1 ~ 14; Body surface area ≥1.5m2: Tegio 60mg bid day 1 ~ 14; 3 cycles before surgery and 3 cycles after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: SOX regimen (oxaliplatin + Seggio) ) + sintilimab + trastuzumab; 3 cycles of treatment, followed by D2 radical resection, and 5 cycles of adjuvant chemotherapy with the original regimen after surgery Receives: Drug: sintilimab; Drug: Trastuzumab; Drug: S-1 plus oxaliplatin |
| Group B | Active comparator | Group B: SOX regimen, 3 cycles of treatment, followed by D2 radical resection, and 5 cycles of adjuvant chemotherapy with the original regimen after surgery Receives: Drug: S-1 plus oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate (MPR)
Proportion of subjects with residual tumor less than 10% or complete response
Measured: Up to 6 months
Secondary outcomes (6)
Pathological response rate (refer to Becker-TRG evaluation standard)
TRG level 1-3:
1a: No tumor remains at all
1b: Less than 10% of the tumor remains 2: 10%-50% tumor residual 3: More than 50% of the tumor remains or there is no change in the tumor
Measured: Up to 3 years
Objective response rate (ORR)
Proportion of subjects with initial RECIST 1.1 measurable disease who have complete response (CR) or partial response (PR) according to iRECIST
Measured: Up to 3 years
Disease-free survival (DFS)
Time from Cycle 1 Day 1 treatment administration to the first documented event of: disease progression, disease recurrence following surgery (preferably biopsy proven), or death - whichever occurs first.
Measured: Up to 3 years
Overall survival (OS)
Time from Cycle 1 Day 1 treatment administration to death due to any cause.
Measured: Up to 3 years
Incicende of Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.
Measured: Up to3 years
Biomarker assessment
To analyze the differences of gene and immune microenvironment biomarkers among patients with different curative effects, and further explore the relationship with the efficacy of clinical treatment.
To analyze the correlation between peripheral blood indexes and the efficacy of clinical treatment.
Measured: Up to3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positiveStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, randomized controlled, exploratory phase II study. Patients with HER2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma who have not received any anti-tumor therapy were randomized in a 1:1 ratio to receive preoperatively: Group A: SOX regimen (oxaliplatin + Seggio) ) + sintilimab + trastuzumab; group B: SOX regimen, 3 cycles of treatment, followed by D2 radical resection, and 5 cycles of adjuvant chemotherapy with the original regimen after surgery
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aiping Zhou
- Responsible party
- Sponsor-investigator, Aiping Zhou, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218148
- Sponsor's protocol ID
- NCC-008261
- Status last verified
- Mar 2022
- First submitted
- 16 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Oxaliplatin Plus S-1 (SOX) Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of Locally Advanced HER2-positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05218148
- Acronym / sponsor ID
- NCC-008261
- Conditions
- HER2-positive, Locally Advanced Solid Tumor, Immunotherapy, Sintilimab, S-1, Oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Aiping Zhou
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Feb 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.
The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer；For HER2-positive locally advanced gastric cancer, some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological remission rate;This prospective phase II clinical trial was designed, using SOX combined with sintilimab and trastuzumab to treat HER2 positive locally advanced gastric or gastroesophageal junction adenocarcinoma patients.
Detailed description
This phase II trial is a single-arm and single-center clinical study. Neoadjuvant chemotherapy is a standard treatment for locally advanced gastric cancer. The SOX regimen has became the standard perioperative chemotherapy regimen for locally advanced gastric cancer. For HER2-positive locally advanced gastric cancer, the neoadjuvant treatment is still based on chemotherapy alone. Some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological response. But it has not yet become a standard treatment strategy.
In the field of gastric cancer, checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer. PD-1 monoclonal antibody (Sintilimab) + trastuzumab + chemotherapy (SOX regimen ) may be an ideal perioperative treatment for HER2-positive locally advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, randomized controlled, exploratory phase II study. Patients with HER2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma who have not received any anti-tumor therapy were randomized in a 1:1 ratio to receive preoperatively: Group A: SOX regimen (oxaliplatin + Seggio) ) + sintilimab + trastuzumab; group B: SOX regimen, 3 cycles of treatment, followed by D2 radical resection, and 5 cycles of adjuvant chemotherapy with the original regimen after surgery
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: sintilimab, Drug: Trastuzumab, Drug: S-1 plus oxaliplatinGroup A: SOX regimen (oxaliplatin + Seggio) ) + sintilimab + trastuzumab; 3 cycles of treatment, followed by D2 radical resection, and 5 cycles of adjuvant chemotherapy with the original regimen after surgery |
| Group B | Active comparator | Drug: S-1 plus oxaliplatinGroup B: SOX regimen, 3 cycles of treatment, followed by D2 radical resection, and 5 cycles of adjuvant chemotherapy with the original regimen after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign the informed consent form.
- Locally advanced adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III) confirmed by pathology or cytology.
- The definition of a positive HER2 test result is as follows: IHC detects HER2 3+ or IHC detects HER2 2+ and FISH is positive.
- Clinically, based on chest, abdomen and pelvic CT, gastroscopy, endoscopic ultrasonography, gastrointestinal contrast, ordinary ultrasound, or laparoscopy if possible, it is judged as T3-4a N+ or T4bN any gastric cancer or gastroesophageal junction cancer (refer to AJCC Article Version 8 in stages).
- Patients have not received chemotherapy and/or immunotherapy and/or trastuzumab treatment and/or radiotherapy in the past.
Key exclusion criteria (9 listed)
- The pathology is other types besides adenocarcinoma, such as squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma and so on.
- Have received chemotherapy and/or radiotherapy in the past.
- Have received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies and other immunotherapy in the past.
- Have received any anti-HER2 therapy in the past.
- Intra-abdominal dissemination or distant metastasis (M1).
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 |
|---|---|---|
| sintilimabSintilimab 200mg was administered as a 30-60 min intravenous (IV) infusion every 3 weeks.3 cycles before surgery and 5 cycles after surgery. | Drug | Group A |
| TrastuzumabTrastuzumab was 8mg/kg for the first time, and 6mg/kg for the follow-up. 3 cycles before surgery and 5 cycles after surgery. | Drug | Group A |
| S-1 plus oxaliplatinOxaliplatin 130 mg/m2 was administered IV every 3 weeks. S-1 was given orally twice daily for the first 2 weeks of each 3-week cycle. The S-1 dose was 40 mg for body surface area (BSA) < 1.25 m2, 50 mg for BSA 1.25 to <1.5 m2 and 60 mg for BSA ≥1.5 m2. Body surface area \<1.25m2: Tegio 40mg bid day 1 ~ 14; Body surface area 1.25 ~ \<1.5m2: Tegio 50mg bid day 1 ~ 14; Body surface area ≥1.5m2: Tegio 60mg bid day 1 ~ 14; 3 cycles before surgery and 3 cycles after surgery. | Drug | Group A, Group B |
Primary outcome
Major pathological response rate (MPR)
Time frame: Up to 6 months
Proportion of subjects with residual tumor less than 10% or complete response
6 secondary outcomes
Pathological response rate (refer to Becker-TRG evaluation standard)
Time frame: Up to 3 years
Objective response rate (ORR)
Time frame: Up to 3 years
Disease-free survival (DFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Incicende of Adverse Events (AEs)
Time frame: Up to3 years
Biomarker assessment
Time frame: Up to3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- 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. This study is not recruiting at the moment.
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 sintilimab, Trastuzumab and S-1 plus oxaliplatin in people with HER2-positive and Locally Advanced Solid Tumor, run by Aiping Zhou 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aiping Zhou, doctor (86 13691161998, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate (MPR) (time frame: Up to 6 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 6 Apr 2022.