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Disorder in Complete Remission in Response to TreatmentPhase 2NCT05563012

Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma

A Phase 2 study testing Sintilimal Injection in people with Disorder in Complete Remission in Response to Treatment, run by Renmin Hospital of Wuhan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sintilimal Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
26 Sep 2022to 1 Oct 2026
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

  • All individuals recruited signed a written informed consent;
  • Aged between 18 and 75 years;
  • Histologically confirmed gastric adenocarcinoma, and Stage III (cT3-4aN1-3 M0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cawas confirmed by enhanced CT/MRI scan (endoscopic ultrasonography (EUS) and laparoscopic exploration if necessary), and the lesion was resectable;
  • No previous systemic therapy, including including surgery, radiotherapy, chemotherapy and immunotherapy, etc；
  • Patients who have no contraindications and consent to radical surgery;
  • Eastern Cooperative Group (ECOG) performance status score 0 or 1;
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  • Expected survival time > 6 months;
  • The main organ function of cases should be normal, and meet the following criteria: ①Absolute neutrophil count (ANC)≥1.5×109/L (no Granulocyte colony-stimulating factor within 14 days prior to enrolment); ②Platelets ≥100×109/L (no blood transfusion within 14 days prior to enrolment); ③Hemoglobin>90g/L (no blood transfusion or no erythropoietin (EPO) dependence within 14 days prior to enrolment); ④Total bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN), such as total bilirubin > 1.5 x ULN but direct bilirubin ≤1.5 x ULN was also allowed to be enrolled; ⑤ALT (glutamic-pyruvic transaminase) and AST (glutamic-oxalacetic transaminase) ≤2.5 × ULN; ⑥Serum Cr≤1.5 × ULN and creatinine clearance ≥60 ml/min (Cockcroft-Gault formula); ⑦International normalized ratio (INR) <1.5 or prothrombin time (PT)≤1.5 ULN; ⑧Thyroid stimulating hormone (TSH) was normal. If TSH was abnormal, subjects with total T3 (or FT3) and FT4 normal could also be enrolled; ⑨Myocardial infarction was normal.
  • Female subjects of reproductive age must conduct pregnancy test (serum or urine) within 3 days before the first study drug administration (day 1 of cycle 1), and the results are negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as those who had been postmenopausal for at least 1 year or who had undergone surgical sterilization or hysterectomy;
  • If there was a risk of conception, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% for the entire treatment period until 120 days after the last administration of the test drugs (or 180 days after the last administration of the chemotherapy drug ).

Who cannot join

  • Other malignancy disease history within five years, with the exception of basal cell carcinoma or squamous carcinoma of skin, and carcinoma in situ that have undergone radical resection;
  • Endoscopic signs of active bleeding in the lesion;
  • Is participating in an interventional clinical study or has received another study drug or used a study device within 4 weeks before the first study drug administration;
  • Prior treatment with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. CTLA-4, OX40, CD137) drugs;
  • Systemic systemic therapy with Chinese patent drugs or immunomodulatory agents (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) with anti-tumor indications was received within 2 weeks before the first study drug administration;
  • Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying agents, glucocorticoids, or immunosuppressants) occurred within 2 years before the first study drug administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;
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  • Had received systemic glucocorticoid therapy (excluding nasal, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first study drug administration;
  • Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
  • Known allergy to drugs used in this study;
  • Unable to intake Capecitabine orally (such as the inability to swallow and intestinal obstruction);
  • Failure to recover from treatment-related toxicity/complications to baseline or grade-1 AEs (except for fatigue and hair loss);
  • Has a known history of HIV infection (HIV 1/2 antibody positive);
  • Untreated active hepatitis B (defined as HBsAg-positive with a detected HBV-DNA copy number greater than the upper limit of normal values in the laboratory at the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: ①With HBV viral load <1000 copies /ml (200 IU/ml) before the first study drug administration, subjects should receive anti-HBV therapy to avoid virus reactivation throughout the study chemotherapy drug treatment; ②For subjects with anti-HBC (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but monitoring of viral reactivation is required;
  • Active HCV-infected subjects (HCV antibody positive with HCV-RNA levels higher then the lower limit of detection);
  • Had received live vaccine within 30 days before the first study drug administration; Note: Inactivated virus vaccine for injection against seasonal influenza is permitted for 30 days before the first study drug administration; However, live attenuated influenza vaccines administered intranasally are not allowed;
  • Pregnant or lactating women;
  • The presence of any severe or uncontrolled systemic disease, e.g; ①The resting ECG showed significant abnormalities in rhythm, conduction or morphology with severe symptoms and difficult to control, such as complete left bundle branch block, degree ⅱ higher heart block, ventricular arrhythmia or atrial fibrillation; ②Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure; ③Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred in the 6 months prior to enrollment; ④Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); ⑤Has a history of noninfectious pneumonia requiring glucocorticoid therapy within 1 year before the first study drug administration or active interstitial lung disease; ⑥Active pulmonary tuberculosis; ⑦Have active or uncontrolled infections requiring systemic therapy; ⑧There are active diverticulitis, abdominal abscess, and gastrointestinal obstruction; ⑨Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; ⑩Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L); ⑪Urine routine indicated urinary protein ≥++, and 24-hour urinary protein > 1.0 g on urine dipstick; ⑫Patients with mental disorders who are unable to actively cooperate with treatment;
  • Subjects are not eligible to participate in the study if they have abnormal medical history or evidence of disease, treatment or laboratory test values that may interfere with the results of the trial or prevent their full participation in the study, or if they have other conditions or potential risks that the investigator considers inappropriate for enrollment.

Trial locations and contacts

1 site in 1 country.

Xiangpan Li, M.D. contact

+86-027-88041911

rm001227@whu.edu.cn

China1 site, 1 recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430061

    Xiangpan Li, M.D., +86-027-88041911, rm001227@whu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Single-arm Phase II Clinical Study of Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma

This is a Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant therapy for locally advanced gastric adenocarcinoma.

Being tested
Sintilimal Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sintilimal InjectionDrug

    Also called Capecitabine, Oxaliplatin

    Sintilimal (200mg) will be given i.v. on day 1 of each 3-week cycle.

Study groups in NCT05563012
Study groupRoleWhat they receive
Patients with untreated, operable locally advanced gastric adenocarcinomaExperimentalDrug: Sintilimal Injection Sintilimal (200mg) will be given i.v. on day 1 of each 3-week cycle. Drug: Capecitabine Capecitabine (1000mg/m2) will be administered orally twice daily on days 1-14 of each 3-week cycle. Drug: Oxaliplatin Oxaliplatin (130mg/m2) will be given i.v. on day 1 of each 3-week cycle.
Receives: Drug: Sintilimal Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pathologic complete response (pCR) rate

    Defined as lack of any viable tumor cells in the surgically removed tumor and lymph node tissues.

    Measured: 36 months

Secondary outcomes (3)

  1. Major pathological response (MPR) rate

    Defined as the proportion of subjects with 10% or less of residual viable tumor cells in the resected primary tumor.

    Measured: 36 months

  2. Disease-free survival (DFS)

    Defined as the time from surgery to the time of first recurrence or death, whichever occurred first.

    Measured: 36 months

  3. overall survival (OS)

    OS is the time from enrollment to death due to any cause. OS is the time from enrollment to death due to any cause. OS is the time from enrollment to death due to any cause.OS is the time from enrollment to death due to any cause.

    OS is the time from enrollment to death due to any cause.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start26 Sep 2022
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563012
Sponsor's protocol ID
WDRY2022-KI78
Status last verified
Sep 2022
First submitted
28 Sep 2022
Last updated
3 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimal Injection in people with Disorder in Complete Remission in Response to Treatment, run by Renmin Hospital of Wuhan 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 18 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 3 Oct 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 Xiangpan Li, M.D. (+86-027-88041911, rm001227@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic complete response (pCR) rate (time frame: 36 months). 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 NCT05563012.

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 3 Oct 2022.

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