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Gastric CancerPhase 2NCT06341595

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM

A Phase 2 study testing Sintilimab, Extraperitoneal radiation therapy and Oxaliplatin in people with Gastric Cancer and Gastric Cancer Metastatic to Regional Lymph Nodes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sintilimab, Extraperitoneal radiation therapy and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Apr 2024to 31 Dec 2026
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide informed consent and willing to sign an approved consent form;
  • age ≥ 18 years old and ≤ 75 years old, male and female;
  • Has histologically confirmed diagnosis of gastric or GEJ adenocarcinoma;
  • patients with advanced gastric cancer who have para aortic lymph node metastasis at the initial treatment and whose primary tumor site can be treated with D2 radical operation;
  • peritoneal exploration to exclude peritoneal metastasis, liver metastasis and other metastasis;
  • CT or MRI, PET-CT and other examinations suggest that there is only one unresectable factor, namely, para aortic lymph node metastasis;
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  • has not receive previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.);
  • Has at least one measurable lesion as defined by RECIST 1.1 as determined by investigator assessment.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • expected survival time >3 months;
  • sufficient organ function, the subject needs to meet the following laboratory indicators:
  • The absolute neutrophil count (ANC) ≥ 1.5x109/l without granulocyte colony stimulating factor in the past 14 days.
  • Platelets ≥ 100 without blood transfusion in recent 14 days × 109/l.
  • Hemoglobin >9g/dl without blood transfusion or use of erythropoietin in recent 14 days;
  • Total bilirubin ≤ 1.5 × Upper limit of normal value (ULN);
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were ≤ 2.5 × ULN (ALT or AST ≤ 5 allowed for subjects with liver metastasis × ULN);
  • Blood creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft Gault formula) ≥ 60 ml/min;
  • Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
  • Thyroid function was normal, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
  • Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment. Women of non-childbearing potential was defined as having a cessation of menses for one or more year or having surgical sterilization/Hysterectomy
  • Participants of childbearing potential must be willing to use an adequate method of contraception （method with failure rate less than 1% in a year）for the course of the study through 120 days after the last dose of study medication or through 180 days of last dose of chemotherapy.

Who cannot join

  • HER-2 positive status
  • peritoneal or other organ metastasis;
  • endoscopy shows signs of active bleeding, and history of gastrointestinal perforation and /or fistula within 6 months before enrollment.;
  • other malignant diseases other than gastric cancer diagnosed within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or carcinoma in situ after radical resection);
  • Is currently participating in and receiving study therapy , or having been treated with another research drug or with an investigational medical devices within 4 weeks before the first administration;
  • Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137);
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  • have received systemic treatment with Chinese patent drugs with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control ascites) within 2 weeks before the first administration;
  • active autoimmune disease requiring systemic treatment (such as the use of disease modifying drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
  • being treated with systemic glucocorticoids (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study;
  • Note: physiological doses of glucocorticoids (≤ 10 mg/ day of prednisone or equivalent) are allowed;
  • Known history of allogeneic organ (except corneal transplantation) or allogeneic hemopoietic stem cell transplantation;
  • Known allergy or hypersensitivity to the investigational drugs Sintilimab, Oxaliplatin, S-1 or excipients;
  • there are many factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, cardiac and pyloric obstruction affecting eating and gastric emptying);
  • have not fully recovered from the toxicity and / or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or reaching baseline, excluding fatigue or hair loss);
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive) (i.e. HIV 1/2 antibody positive);
  • uncontrolled active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);
  • Note: hepatitis B subjects who meet the following criteria can also be enrolled:
  • HBV viral load was <1000 copies /ml (200 iu/ml) before the first dose, and subjects should receive anti HBV treatment throughout the study drug treatment period to avoid virus reactivation
  • For subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), prophylactic anti HBV treatment is not required, but viral reactivation needs to be closely monitored
  • active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
  • vaccinated with live vaccine within 30 days before the first administration (cycle 1, day 1);
  • Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasally are not allowed.
  • Women who are pregnant or nursing.
  • there are any serious or uncontrollable systemic diseases, such as:
  • The resting ECG has major abnormalities in rhythm, conduction or morphology, and the symptoms are serious and difficult to control, such as complete left bundle branch block, heart block above grade II, ventricular arrhythmia or atrial fibrillation;
  • Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ 2;
  • Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before enrollment;
  • Blood pressure control was not ideal (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
  • There was a history of non infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there was currently clinically active interstitial lung disease;
  • Active pulmonary tuberculosis;
  • The presence of active or uncontrolled infections requiring systemic treatment;
  • There were clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
  • Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
  • Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/l);
  • The urine routine showed that the urine protein was ≥ + +, and the 24-hour urine protein quantitation was confirmed to be > 1.0 G;
  • Those who have mental disorders and cannot cooperate with treatment;
  • Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in 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.

Yan Yang contact

13512517281

yy17281@aliyun.com

Dongdong Gu contact

13815440993

654034729@qq.com

China1 site, 1 recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Yang Yan

    Recruiting

Other trials in China

About this study

Official title: Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis: a Single-arm, Phase II, Exploratory Study.

This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy.

Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.

Being tested
Sintilimab, Extraperitoneal radiation therapy, Oxaliplatin, S-1
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, 4-6 cycles

  • Extraperitoneal radiation therapyRadiation

    Radiotherapy using extraperitoneal radiation therapy, once a day, 5 times a week, 1.8-2 Gy/f, a total of 45-50.4 Gy (lymph node lesion radiation dose of 60-66 Gy)

  • OxaliplatinDrug

    oxaliplatin: 130mg/m^2, D1, Q3W, 4-6 cycles

  • S-1Drug

    S-1: 40mg/m^2, bid, d1-14, 4-6 cycles

Study groups in NCT06341595
Study groupRoleWhat they receive
combination therapyExperimentalsintilimab combined with chemotherapy and radiotherapy
Receives: Drug: Sintilimab; Radiation: Extraperitoneal radiation therapy; Drug: Oxaliplatin; Drug: S-1

What is being measured

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

  1. Recurrence free survival (RFS)

    Recurrence free survival of patients undergoing surgery after Sintilimab Injection combined with concurrent chemoradiotherapy

    Measured: 24 months

Secondary outcomes (5)

  1. R0 resection rate

    Proportion of patients with R0 resection who underwent surgery in all enrolled patients.

    Measured: 12 months

  2. Objective response rate (ORR)

    Proportion of participants in complete and partial remission

    Measured: 24 months

  3. Major pathological response rate (MPR)

    Proportion of patients with residual survival tumor ≤ 10% in all enrolled patients during surgery

    Measured: 12 months

  4. Overall survival (OS)

    Median survival time of all subjects from enrollment to death from any cause

    Measured: 24 months

  5. 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.

  1. First posted2 Apr 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341595
Sponsor's protocol ID
123322
Status last verified
Jan 2024
First submitted
14 Nov 2023
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab, Extraperitoneal radiation therapy and Oxaliplatin in people with Gastric Cancer and Gastric Cancer Metastatic to Regional Lymph Nodes, 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 21 inclusion and 37 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 2 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.

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?

Recurrence free survival (RFS) (time frame: 24 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 NCT06341595.

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 2 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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