Gastric CancerPhase 2NCT06555471
A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer
A Phase 2 study testing Sintilimab, S-1 and Capecitabine in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer. Participants will: Take sintilimab (200mg iv q3w d1) combined with chemoradiation. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Sintilimab, S-1 and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 31 Dec 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histopathologically confirmed locally advanced (T3-4N+M0) adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma).
- HER-2 negative.
- Age ≥75 years.
- ECOG PS score of 0-2
- have at least one measurable lesion or assessable lesion according to RECIST v1.1.
- have adequate organ and bone marrow function as defined below:
Show all 14Show fewer
- Haematology: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; haemoglobin level ≥ 9.0 g/dL.
- Liver function: Serum total bilirubin (TBIL) ≤ 1.5× the upper limit of normal (ULN); for patients with liver metastases or a history/suspicion of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unconjugated hyperbilirubinemia without evidence of hemolysis or liver disease), TBIL ≤ 3× ULN; for patients without hepatocellular carcinoma (HCC) and liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN; for patients with HCC or liver metastases, ALT or AST ≤ 5× ULN.
- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min; urine protein < 2+ on urine test paper.
- Coagulation function: activated partial thromboplastin time (APTT) and international normalised ratio (INR) ≤ 1.5×ULN.
- Cardiac enzyme profile within normal range
- Normal thyroid function, defined as thyrotropin (TSH) within normal range. If baseline TSH is outside the normal range, subjects may also be enrolled if total T3 (or FT3) and FT4 are within the normal range;
- expected survival time ≥ 12 weeks;
- Signed written informed consent and able to comply with protocol-specified visits and related procedures.
Who cannot join
- known endoscopic signs of active bleeding from the lesion.
- Near obstruction of the cardia and pylorus affecting feeding and gastric emptying, or impaired swallowing of tablets.
- Diagnosis of HER-2 positive adenocarcinoma of the stomach and gastro-oesophageal junction.
- Previous systemic therapy for advanced or metastatic adenocarcinoma of the stomach and gastro-oesophageal junction.
- Malignant disease other than gastric cancer diagnosed within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ);
- Currently being treated in an interventional clinical study or have been treated with another investigational drug or with an investigational device within 4 weeks prior to the first dose;
Show all 32Show fewer
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulatory or synergistic inhibitor of T-cell receptors (e.g., CTLA-4, OX-40, CD137);
- active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating medications, glucocorticoids, or immunosuppressive agents) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy;
- are receiving systemic glucocorticoid therapy (excluding topical glucocorticosteroids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted;
- known for allogeneic organ transplantation (except corneal transplantation) or allogeneic haematopoietic stem cell transplantation;
- Known allergy (grade 3 or higher) to any monoclonal antibody or component of a chemotherapeutic drug (Tegretol/Capecitabine) preparation;
- has not fully recovered from toxicity and/or complications resulting from any intervention prior to initiation of therapy (i.e., ≤ Grade 1 or at baseline, excluding malaise or alopecia);
- known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positivity with a detectable HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study centre); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled:
- HBV viral load <1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the duration of study chemotherapeutic drug treatment to avoid viral reactivation;
- For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required but close monitoring of viral reactivation is needed.
- Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
- Live vaccination within 30 days prior to the first dose (Cycle 1, Day 1); NOTE: Receipt of injectable inactivated viral vaccine against seasonal influenza within 30 days prior to the first dose is permitted; however, receipt of live attenuated influenza vaccine administered intranasally is not permitted.
- the presence of any serious or uncontrolled systemic illness, such as:
- Significant and symptomatic uncontrollable abnormalities in rhythm, conduction or morphology of the resting electrocardiogram, such as complete left bundle branch block, heart block of degree II or greater, ventricular arrhythmia or atrial fibrillation;
- Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ grade 2;
- Any arterial thrombosis, embolism or ischaemia such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischaemic attack within 6 months prior to enrolment for treatment;
- Unsatisfactory control of blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
- History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease;
- Active tuberculosis;
- Presence of active or uncontrolled infection requiring systemic therapy;
- Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
- Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- Poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L);
- Urine routine suggestive of urinary protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g;
- Patients with mental disorders who are unable to co-operate with treatment;
- A medical history, evidence of disease, treatment, or abnormal laboratory test results that could potentially interfere with the study results or hinder the participant's full involvement in the research, or any other situation that the investigator deems unsuitable for inclusion in the study, or the investigator believes there are other potential risks that make the participant unsuitable for this study
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
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Yan Yang
About this study
This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer.
Participants will:
Read more
Take sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy.
Subjects undergo an initial assessment of imaging, physical status, quality of life, and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy, followed by assessments every 2 months, and after 3 full assessments, assessments every 3 months are initiated.
- Conditions
- Gastric Cancer
- Being tested
- Sintilimab, S-1, Capecitabine, Extraperitoneal radiation 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.
SintilimabDrug
Sintilimab: 200mg iv q3w d1
S-1Drug
po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time)
CapecitabineDrug
1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.
Extraperitoneal radiation therapyRadiation
once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| combination therapy sintilimab combined with chemotherapy and radiotherapy | Experimental | Sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy.
Maintenance therapy with sintilimab in combination with S-1 (po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.) up to 2 years. Receives: Drug: Sintilimab; Drug: S-1; Drug: Capecitabine; Radiation: Extraperitoneal radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Proportion of participants in complete and partial remission
Measured: 24 months
Disease control rate (DCR)
the proportion of patients who achieve tumor relief (PR+CR) and stable disease (SD)
Measured: 24 months
Duration of response (DoR)
the time from onset of response to progression or death due to any reason, whichever occurs earlier
Measured: 24 months
Progression free survival (PFS)
the time from initiation of treatment to the occurrence of disease progression or death, whichever occurs earlier.
Measured: 24 months
Secondary outcomes (2)
Overall survival
the time from initiation of treatment to death caused by any reasons.
Measured: 24 months
Adverse reactions
According to the adverse event data of CTCAE version 5.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start6 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 The First Affiliated Hospital with Nanjing Medical 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555471
- Sponsor's protocol ID
- 123323
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06555471
- Acronym / sponsor ID
- 123323
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Aug 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.
This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer.
Participants will:
Take sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy.
Subjects undergo an initial assessment of imaging, physical status, quality of life, and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy, followed by assessments every 2 months, and after 3 full assessments, assessments every 3 months are initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination therapy sintilimab combined with chemotherapy and radiotherapy | Experimental | Drug: Sintilimab, Drug: S-1, Drug: Capecitabine, Radiation: Extraperitoneal radiation therapySintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy. Maintenance therapy with sintilimab in combination with S-1 (po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.) up to 2 years. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Histopathologically confirmed locally advanced (T3-4N+M0) adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma).
- HER-2 negative.
- Age ≥75 years.
- ECOG PS score of 0-2
- have at least one measurable lesion or assessable lesion according to RECIST v1.1.
Key exclusion criteria (32 listed)
- known endoscopic signs of active bleeding from the lesion.
- Near obstruction of the cardia and pylorus affecting feeding and gastric emptying, or impaired swallowing of tablets.
- Diagnosis of HER-2 positive adenocarcinoma of the stomach and gastro-oesophageal junction.
- Previous systemic therapy for advanced or metastatic adenocarcinoma of the stomach and gastro-oesophageal junction.
- Malignant disease other than gastric cancer diagnosed within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ);
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 iv q3w d1 | Drug | combination therapy sintilimab combined with chemotherapy and radiotherapy |
| S-1po d1-d14，q3w； according to body surface area ：<1.5m^2 40mg/time；1.5~1.8m^2 50mg/time；>1.8m2 60mg/time) | Drug | combination therapy sintilimab combined with chemotherapy and radiotherapy |
| Capecitabine1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject. | Drug | combination therapy sintilimab combined with chemotherapy and radiotherapy |
| Extraperitoneal radiation therapyonce a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy | Radiation | combination therapy sintilimab combined with chemotherapy and radiotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months
Proportion of participants in complete and partial remission
Disease control rate (DCR)
Time frame: 24 months
the proportion of patients who achieve tumor relief (PR+CR) and stable disease (SD)
Duration of response (DoR)
Time frame: 24 months
the time from onset of response to progression or death due to any reason, whichever occurs earlier
Progression free survival (PFS)
Time frame: 24 months
the time from initiation of treatment to the occurrence of disease progression or death, whichever occurs earlier.
2 secondary outcomes
Overall survival
Time frame: 24 months
Adverse reactions
Time frame: 24 months
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 15 Aug 2024.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
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, S-1 and Capecitabine in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 14 inclusion and 32 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 15 Aug 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 Yan Yang (13512517281, yy17281@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 24 months). The study lists 4 primary outcomes in all. 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 15 Aug 2024.