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Gastric CancerPhase 2/3NCT05002686

Safety and Efficacy of Sintilimab in Combination With Chemoradiothrapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis

A Phase 2/3 study testing Sintilimab, Albumin-Paclitaxel and Capecitabine in people with Gastric Cancer, run by Ruijin Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Gastric cancer with retroperitoneal lymph node metastasis was considered as unresectable, to improve these patients' prognosis, we designed systematic conversion therapy including immunotherapy and chemoradiotherapy. 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, Albumin-Paclitaxel and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
7 Aug 2021to 1 Aug 2024
Phase
Phase 2/3
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

  • Pathology confirmed Gastric/Gastricgastroesophageal junction adenocarcinoma;
  • Radiolgical imging including CT,PET-CT or MRI diagnosed as retroperitoneal metastasis.
  • Did not receive previous systemic treatment (chemotheray, radiotherapy or both) for advanced disease before.
  • ECOG PS 0-2.
  • Adequate organ and bone marrow functions and life expectancy ≥12 weeks.

Who cannot join

  • Distant metastases except retroperitoneal metastasis (liver, lung, peitoneal metastasis...);
  • HER2-positive status;
  • Suspicious active bleeding or gastriointestineal obstruction phenomenon and Has difficulty in swallow tablets and food;
  • 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
  • Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
  • Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
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  • Known acute or chronic active hepatitis B infection (positive HBsAg and HBV DNA ≥ 200 IU/mL or ≥ 10^3 copies/mL positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection.
  • Women who are pregnant or nursing.
  • Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia or Grave's disease, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or type I diabetes mellitus only requiring insulin replacement, but not required systemic treatment in the last 2 years, are permitted to enroll) .
  • Known primary immunodeficiency.
  • Known active tuberculosis.
  • Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
  • Known>=grade 3 allergy or hypersensitivity to Albumin-paclitaxel oxaliplatin, capecitabine or any monoclonal antibodies.
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive).
  • Poorly controlled arterial hypertension (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) with standard treatment .
  • Symptomatic congestive heart failure (New York Heart Association grade II-IV) or symptomatic, poorly controlled arrhythmia.
  • Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment.
  • Active or poorly controlled severe infection.
  • History of gastrointestinal perforation and /or fistula within 6 months before enrollment.
  • 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.

Changyu He, PhD contact

8618817821339

hechangyu.2008@163.com

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    Chen Li, PhD, MD, 8602164370045, leedoctor@sina.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Sintilimab in Combination With Albumin-Paclitaxel/Oxaliplatin/Capecitabine and Radiotherapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis: A Multiple Center Single Arm Trial

Gastric cancer with retroperitoneal lymph node metastasis was considered as unresectable, to improve these patients' prognosis, we designed systematic conversion therapy including immunotherapy and chemoradiotherapy. The purpose of this study is to estimate safety and efficacy of Sintilimab in combination with chemoradiothrapy followed by D2 surgical resection in patients with advanced gastric cancer with retroperitoneal lymph node metastasis.

Conditions
Gastric Cancer
Being tested
Sintilimab, Albumin-Paclitaxel, Capecitabine, Oxaliplatin, Radiation
Keywords
retroperitoneal lymph node metastasis, chemoradiotherapy, surgical resection
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

    200 mg Q3W on Day 1 by IV infusion

  • Albumin-PaclitaxelDrug

    200 mg/m^2 Q3W on Day 1 by IV infusion

  • CapecitabineDrug

    1000 mg/m^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14

  • OxaliplatinDrug

    130 mg/m^2 Q3W on Day 1 by IV infusion

  • RadiationRadiation

    Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy*25.

  • Radical gastric cancer surgeryProcedure or surgery

    Radical gastric cancer surgery with D2 lymph node dissection

Study groups in NCT05002686
Study groupRoleWhat they receive
Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical ResectionExperimentalNot described
Receives: Drug: Sintilimab; Drug: Albumin-Paclitaxel; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiation; Procedure: Radical gastric cancer surgery

What is being measured

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

  1. 1 year Progression Free Survival (PFS)

    Measured: Approximately 3 years after the first participant is included

Secondary outcomes (5)

  1. R0 surgical resection percentage

    Measured: Approximately 2 years after the first participant is included

  2. Operative conversion percentage

    Measured: Approximately 2 years after the first participant is included

  3. Overall survival (OS)

    Measured: Approximately 4 years after the first participant is included

  4. Number of participants experiencing clinical and laboratory adverse events (AEs)

    Measured: Approximately 4 years after the first participant is included

  5. Percentage of pathologic complete response(pCR)

    Measured: Approximately 2 years after the first participant is included

Timeline

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

  1. First posted12 Aug 2021
  2. Study start7 Aug 2021
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion1 Aug 2024 (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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002686
Sponsor's protocol ID
Dragon VIII
Status last verified
Aug 2021
First submitted
10 Aug 2021
Last updated
24 Aug 2021
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 2/3 study testing Sintilimab, Albumin-Paclitaxel and Capecitabine in people with Gastric Cancer, run by Ruijin Hospital 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 5 inclusion and 21 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 24 Aug 2021. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Changyu He, PhD (8618817821339, hechangyu.2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year Progression Free Survival (PFS) (time frame: Approximately 3 years after the first participant is included). 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 NCT05002686.

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 24 Aug 2021.

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