Gastric CancerPhase 2NCT04065282
The Purpose of This Study is to Evaluate the Efficacy and Safety of Sintilimab in Combination With Xelox as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
A Phase 2 study testing Sintilimab, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) as Neoadjuvant Therapy in patients With Resectable Locally Advanced Gastric Cancer 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?
- Sintilimab, Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2019to 1 Mar 2022
- 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
- Histologically proven adenocarcinoma of the stomach.
- The primary tumor locates at stomach or esophagogastroesophageal ic junction.
- Clinical T3-4NxM0 disease, confirmed by enhanced contrast abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
- At least one measurable lesion.
- Resectable gastric or gastroesophageal cancer, judged by surgeons in this studyEligible and reasonably suitable for potentially curative resection
- ECOG performance status 0-1.
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- Adequate organ function for chemotherapy and surgical treatment, as evaluated by laboratory tests.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Agree to use an approved contraceptive method during the treatment period, until 120 days after last dose of Sintilimab or 180 days after last dose of chemotherapy.
Who cannot join
- Unsectable primary tumor or any distant metastatic disease.
- Received any anti-cancer therapy for this disease, including radiation therapies, chemotherapies, immunotherapies, and Chinese traditional herb therapies.
- Clinical T1-2N0M0 disease, confirmed by CT/MRI or endoscopic ultrasonography.
- Active autoimmune disease or history of refractory autoimmune disease.
- History of any other malignant tumor within 2 years, excluding cured local tumor, such as resected skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or ductal carcinoma in situ (DCIS).
- History of gastrointestinal hemorrhage within 2 weeks before enrollment or patients with a high risk of hemorrhage.
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- History of gastrointestinal perforation within 6 months before enrollment.
- Gastrointestinal obstruction, gastrointestinal dysfunction, or malabsorption syndrome that may affect the absorption of Capecitabine.
- Weight loss is greater than 20% within 2 months before enrollment.
- History of severe pulmonary disease, including but not limited to interstitial pulmonary disease, noninfectious pneumonitis, pulmonary fibrosis, acute pulmonary disease
- Uncontrolled systematic disease, including diabetes mellitus, hypertension, etc.
- Severe chronic or active infectious disease that needs systematic antibiotics, antifungal, or antiviral therapies.
- Untreated chronic hepatitis B, serum HBV DNA load higher than the lower threshold of the test, or HCV RNA positive.
- With any cardiovascular risk factors as follow:
- History of angina within 28 days before enrollment, defined as moderate pain affecting daily activities;
- History of symptomatic pulmonary embolism within 28 days before enrollment;
- History of acute myocardial infarction within 6 months before enrollment;
- History of NYHA class III/IV heart failure within 6 months before enrollment;
- History of grade 2 (Lown grading system) or menopause ventricular arrhythmias or history of supraventricular arrhythmias that needs treatment within 6 months before enrollment;
- History of cerebrovascular accident within 6 months before enrollment;
- grade 1 Peripheral neuropathy , excluding patients with only deep tendon reflex absence.]
- Known Dihydropyrimidine dehydrogenase (DPD) deficiency.
- Known allergic to any drug used in this study.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Receiving corticosteroid (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies:
- steroid hormone replacement therapy (≤10mg/d);
- local steroid therapy;
- short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting
- Receiving attenuated vaccine within 4 weeks before enrollment.
- Receiving immunotherapy or other study drugs within 28 days before enrollment,
- History of receiving anti-PD-1, anti-PD-L1, anti-PD-L2, or any other T cell co-simulation or checkpoint inhibitor therapy.
- Receiving major surgery within 28 days before enrollment.
- For patients with uncontrolled epilepsy, central nervous system disease, or mental disorder, researchers should evaluate if the inform consent and/or the compliance would be affected by their disease.
- Any drug or alcohol abuse that would affect drug management or toxicity analysis.
- Pregnant or nursing female.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Zhejiang
haiping jiang, PhD, 0571-87235896, lsteng@zju.edu.cn
About this study
Official title: A Prospective, Multicenter, Single-armed, Phase II Study Evaluating Efficacy and Safety of Neoadjuvant Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) as Neoadjuvant Therapy in patients With Resectable Locally Advanced Gastric Cancer
Read the detailed description
This prospective, multicenter, single-armed, phase II study will evaluate efficacy and safety of Sintilimab in combination with Xelox (Oxaliplatin 130mg/m2 iv d1 Q3w and Capecitabine 1000mg/m2 po Bid d1-14 Q3W) as neoadjuvant therapy in patients with resectable locally advanced gastric or gastroesophageal adenocarcinoma(G/GEJ AC). Newly diagnosed, treatment naïve patients with resectable locally advanced gastric or G/GEJ AC will be eligible to receive up to 3 cycles of sintilimab plus Xelox regimen as neoadjuvant therapy. Following radical gastrectomy will be performed within one to four weeks since last dosing for patients with resectable cancer after radiological evaluation.
- Conditions
- Gastric Cancer
- Being tested
- Sintilimab, Oxaliplatin, Capecitabine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called IBI308
3 cycles before radical surgery
OxaliplatinDrug
85mg/m2 Q3W, 3 cycles perioperation
CapecitabineDrug
1000mg/m2 bid po D1~14 Q3W, 3 cycles perioperation
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant therapy with Sintilimab plus Xelox | Experimental | 3 cycles of neoadjuvant therapy: Sintilimab iv d1 Q3W, Oxaliplatin 130mg/m2 iv d1 Q3W, and Capecitabine 1000mg/m2 po Bid d1-14 Q3W Receives: Drug: Sintilimab; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.
Measured: after surgical resection (up to 12 weeks after first dosing)
Secondary outcomes (5)
Objective response rate (ORR)
Measured: 9 to 12 weeks
Tumor regression grade (TRG)
Measured: after surgical resection (up to 12 weeks after first dosing)
Disease free survival (DFS)
Measured: every 90 days after resection, up to 2 years
1-year overall survival rate
Measured: 1 years
2-year overall survival rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start6 Aug 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Model description
- neoadjuvant chemotherapy sintilimab plus XELOX
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jianghaiping, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065282
- Sponsor's protocol ID
- CIBI308Y030
- Status last verified
- Feb 2020
- First submitted
- 15 Aug 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang H, Yu X, Li N, Kong M, Ma Z, Zhou D, Wang W, Wang H, Wang H, He K, Li Z, Lu Y, Zhang J, Zhao K, Zhang Y, Xu N, Li Z, Liu Y, Wang Y, Wang Y, Teng L. Efficacy and safety of neoadjuvant sintilimab, oxaliplatin and capecitabine in patients with locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma: early results of a phase 2 study. J Immunother Cancer. 2022 Mar;10(3):e003635. doi: 10.1136/jitc-2021-003635.
PubMed 35296556
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-armed, Phase II Study Evaluating Efficacy and Safety of Neoadjuvant Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT04065282
- Acronym / sponsor ID
- CIBI308Y030
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 22 Aug 2019 (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.
Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) as Neoadjuvant Therapy in patients With Resectable Locally Advanced Gastric Cancer
Detailed description
This prospective, multicenter, single-armed, phase II study will evaluate efficacy and safety of Sintilimab in combination with Xelox (Oxaliplatin 130mg/m2 iv d1 Q3w and Capecitabine 1000mg/m2 po Bid d1-14 Q3W) as neoadjuvant therapy in patients with resectable locally advanced gastric or gastroesophageal adenocarcinoma(G/GEJ AC). Newly diagnosed, treatment naïve patients with resectable locally advanced gastric or G/GEJ AC will be eligible to receive up to 3 cycles of sintilimab plus Xelox regimen as neoadjuvant therapy. Following radical gastrectomy will be performed within one to four weeks since last dosing for patients with resectable cancer after radiological evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- neoadjuvant chemotherapy sintilimab plus XELOX
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant therapy with Sintilimab plus Xelox | Experimental | Drug: Sintilimab, Drug: Oxaliplatin, Drug: Capecitabine3 cycles of neoadjuvant therapy: Sintilimab iv d1 Q3W, Oxaliplatin 130mg/m2 iv d1 Q3W, and Capecitabine 1000mg/m2 po Bid d1-14 Q3W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven adenocarcinoma of the stomach.
- The primary tumor locates at stomach or esophagogastroesophageal ic junction.
- Clinical T3-4NxM0 disease, confirmed by enhanced contrast abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
- At least one measurable lesion.
- Resectable gastric or gastroesophageal cancer, judged by surgeons in this studyEligible and reasonably suitable for potentially curative resection
Key exclusion criteria (35 listed)
- Unsectable primary tumor or any distant metastatic disease.
- Received any anti-cancer therapy for this disease, including radiation therapies, chemotherapies, immunotherapies, and Chinese traditional herb therapies.
- Clinical T1-2N0M0 disease, confirmed by CT/MRI or endoscopic ultrasonography.
- Active autoimmune disease or history of refractory autoimmune disease.
- History of any other malignant tumor within 2 years, excluding cured local tumor, such as resected skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or ductal carcinoma in situ (DCIS).
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 |
|---|---|---|
| SintilimabAlso: IBI3083 cycles before radical surgery | Drug | neoadjuvant therapy with Sintilimab plus Xelox |
| Oxaliplatin85mg/m2 Q3W, 3 cycles perioperation | Drug | neoadjuvant therapy with Sintilimab plus Xelox |
| Capecitabine1000mg/m2 bid po D1~14 Q3W, 3 cycles perioperation | Drug | neoadjuvant therapy with Sintilimab plus Xelox |
Primary outcome
Pathological complete response rate (pCR)
Time frame: after surgical resection (up to 12 weeks after first dosing)
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.
5 secondary outcomes
Objective response rate (ORR)
Time frame: 9 to 12 weeks
Tumor regression grade (TRG)
Time frame: after surgical resection (up to 12 weeks after first dosing)
Disease free survival (DFS)
Time frame: every 90 days after resection, up to 2 years
1-year overall survival rate
Time frame: 1 years
2-year overall survival rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Derived from this study: PubMed 35296556Jiang H, Yu X, Li N, Kong M, Ma Z, Zhou D, Wang W, Wang H, Wang H, He K, Li Z, Lu Y, Zhang J, Zhao K, Zhang Y, Xu N, Li Z, Liu Y, Wang Y, Wang Y, Teng L. Efficacy and safety of neoadjuvant sintilimab, oxaliplatin and capecitabine in patients with locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma: early results of a phase 2 study. J Immunother Cancer. 2022 Mar;10(3):e003635. doi: 10.1136/jitc-2021-003635.
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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, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by First Affiliated Hospital of Zhejiang University 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 35 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 10 Feb 2020. 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 Haiping Jiang, PhD (0571-87235896, jianghaiping75@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 rate (pCR) (time frame: after surgical resection (up to 12 weeks after first dosing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065282, which also lists 1 linked publication.
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 10 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.