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Gastric and Esophagogastric Junction AdenocarcinomaPhase 2NCT04341857

PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma

A Phase 2 study testing PD-1 Monoclonal Antibody(Sintilimab) in people with Gastric and Esophagogastric Junction Adenocarcinoma, run by Henan Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective single arm phase II clinical study to compare the safety and efficacy of PD-1monoclonal antibody +FLOT in patients with gastric adenocarcinoma/esophagus-gastric junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PD-1 Monoclonal Antibody(Sintilimab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
30 Jul 2019to 30 Jul 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

  • Informed consent has been signed;
  • Only patients aged 18-75 were enrolled;
  • Pathologically confirmed gastric adenocarcinoma (cT4 or/and N+M0, MDT considers perioperative treatment necessary) :Bone scan should be performed if bone metastasis is suspected.If peritoneal metastasis is suspected, laparoscopy should be performed;
  • No previous cytotoxic chemotherapy or targeted therapy;
  • No previous local resection of the tumor;
  • ECOG 1 or less;
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  • Tumor specimens capable of detecting PDL-1 and MSI status are available.The detection of PDL-1 and MSI will be conducted after random grouping.This test requires the patient to provide a paraffin-embedded biopsy specimen;
  • Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without transfusion, absolute value of neutrophils (ANC) without granulocyte stimulation factor ≥ 1.5×109/L, and hemoglobin≥ 90 g/L;
  • Bilirubin ≤ 1.5 times of the upper limit of normal value, and rice grass and rice propyl transaminase ≤ 2.5 times of the upper limit of normal value;
  • Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR>45ml/min;
  • Serum albumin ≥ 25g /L (2.5g /dL);
  • INR or aPTT ≤1.5 times ULN;

Who cannot join

  • Allergy to any experimental drug and its excipients, or a history of severe allergy, or a contraindication to the experimental drug;
  • Ahistory of autoimmune diseases or active stage;
  • Previous allogeneic bone marrow transplantation or organ transplantation;
  • Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or ct-confirmed active pneumonia;
  • HIV test positive;
  • Active hepatitis b or c;
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  • Active tuberculosis;
  • Uncontrolled cancer pain;
  • Live attenuated vaccine was injected within 4 weeks before the study began, or live attenuated vaccine was expected to be injected during the trial or within 5 months after the trial;
  • Previous immunotherapy, including CTLA4, anti-pd-1, or anti-pdl1 monoclonal antibody;
  • CT suggested active pulmonary inflammation;
  • Systemic application of glucocorticoids or immunosuppressants within 2 weeks before the start of the trial.Inhaled glucocorticoids and glucocorticoids are allowed;
  • There are taboos on hormone use;
  • Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina within 3 months before the start of the trial;
  • Uncontrolled increase in blood pressure or blood sugar;
  • Other malignancies prior to 5 years, with the exception of cervical carcinoma in situ, non-melanoma skin cancer, or stage I uterine cancer;
  • Known central nervous system metastases;
  • Peripheral neuropathy ≥ NCI CTCAE grade 2;
  • Serum albumin below 2.5 g/dL;
  • Uncontrolled or symptomatic hypercalcemia;
  • Infections requiring antibiotics within 14 days prior to the start of the trial;
  • Chronic enteritis;
  • Clinically significant active gastrointestinal bleeding;
  • Non-diagnostic surgery within 4 weeks before the start of the trial;
  • Any other disease where there is evidence of a need to restrict the use of the experimental drug;
  • Participate in other tests within 30 days before the start of the test, or plan to participate in other tests during the test;
  • Receive other experimental drugs within 28 days prior to the start of the trial;
  • Pregnantor lactating women, or women who plan to become pregnant within 5months after the end of treatment.Women of childbearing age should undergo a blood pregnancy test within 7 days of the start of the trial.

Trial locations and contacts

1 site in 1 country.

Jing Ding, MD contact

13526501903

lining97@126.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Ning Li, PhD, 13526501903, lining97@126.com

    Ning LI, PhD

    Recruiting

Other trials in China

About this study

Official title: Phase II Clinical Study of PD-1 Monoclonal Antibody (Sintilimab) Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma/ Esophagogastric Junction Adenocarcinoma

This is a prospective single arm phase II clinical study to compare the safety and efficacy of PD-1monoclonal antibody +FLOT in patients with gastric adenocarcinoma/esophagus-gastric junction adenocarcinoma.

Read the detailed description

Into a set of 25 cases of the gastric carcinoma confirmed by pathology or gastroesophageal junction adenocarcinoma (cT4 and/or N + M0, Multi-Disciplinary Team thought line to perioperative treatment) patients, preoperative accept four cycle by bead a resistance + sintilimab + capecitabine plus oxaliplatin into new adjuvant chemotherapy, because PD1 antibodies distance between surgery time interval is the lack of clinical data, judging by the researchers is 4 cycles of chemotherapy combination of sintilimab .The patient was able to undergo D2 radical surgery.Pathological examination was carried out to observe the pCR and the infiltration rate of immune cells.After the operation, patients continued to receive 4 cycles of capecitabine + oxaliplatin adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.Disease-free survival time and safety of treatment were observed, and OS, ORR and quality of life of all patients were followed up.

Being tested
PD-1 Monoclonal Antibody(Sintilimab)

What participants receive

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

  • PD-1 Monoclonal Antibody(Sintilimab)Drug

    Sintilimab combined with FLOT regimen,Docetaxel#50mg/m2d1,iv infusion for 1 hour#,Oxaliplatin#80mg/m2d1#iv infusion for 2 hours#,Calcium,leucovate#200mg/m2d1#iv infusion# ,Fluorouracil#2600mg/m2,intravenous drip for 24h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.

Study groups in NCT04341857
Study groupRoleWhat they receive
Sintilimab combined with FLOT regimenExperimentalOxaliplatin#80mg/m2d1#iv infusion for 2 hours# Calcium leucovate#200mg/m2d1#iv infusion# Fluorouracil#2600mg/m2,intravenous drip for 24h# Docetaxel#50mg/m2,intravenous drip for 1 h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.
Receives: Drug: PD-1 Monoclonal Antibody(Sintilimab)

What is being measured

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

  1. Pathological complete response (pCR) rate

    Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the surgical specimens (see WHO solid tumor efficacy criteria

    Measured: immediately after surgery

Secondary outcomes (1)

  1. Disease free survival(DFS)

    The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first. Patients with new non-breast cancer malignancy must continue to be followed for progression of the original breast cancer. For patients without progression, follow-up is censored at the date of last disease assessment without progression, unless death occurs within 12 weeks following the date last known progression-free, in which case the death will be counted as a DFS event.

    Measured: From the date of first treatment dose until documented disease progression or death from any cause. whichever occur first, assessed up to 30 months

Timeline

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

  1. First posted10 Apr 2020
  2. Study start30 Jul 2019
  3. Primary completion30 May 2022 (estimated)
  4. Study completion30 Jul 2022 (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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04341857
Sponsor's protocol ID
HN20190929
Status last verified
Aug 2021
First submitted
1 Apr 2020
Last updated
24 Aug 2021
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 PD-1 Monoclonal Antibody(Sintilimab) in people with Gastric and Esophagogastric Junction Adenocarcinoma, run by Henan Cancer 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 12 inclusion and 28 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 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 Jing Ding, MD (13526501903, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: immediately after surgery). 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 NCT04341857.

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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