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Stage IIIC Gastric CancerPhase 1/2NCT04781413

Nab-PTX Plus S-1 and Sintilimab as Adjuvant Therapy in Patients With Stage IIIC Gastric Cancer

A Phase 1/2 study testing Nab-PTX, Sintilimab, S-1 in people with Stage IIIC 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In this study, we combine Nab-PTX, S-1 and sintilimab as adjuvant regimen to patients with stage IIIC GC. We are aiming to investigate the recommended dose of this regimen in a phase I study and estimate the toxicity and efficacy of this regimen in a phase II study. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stage IIIC Gastric Cancer
What is being tested?
Nab-PTX, Sintilimab, S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
1 Mar 2021to 1 Mar 2024
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years to 80 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Primary gastric cancer or gastroesophageal junction cancer that is pathologically diagnosed as adenocarcinoma;
  • Patients who have underwent radical resection with D2 lymphadenectomy and histologically proven to be stage IIIC gastric cancer according to the 8th edition of the UICC/AJCC TNM staging system for gastric cancer[29];
  • Patients who have received no prior chemotherapy or radiotherapy or immunotherapy for gastric cancer or gastroesophageal junction cancer;
  • No peritoneal metastasis by laparoscopy and no tumor cells in peritoneal fluid on cytologic analysis;
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  • Adequate organ function for chemotherapy as follows:
  • absolute neutrophil count of ≥1.5×109/L;
  • platelet count of ≥100×109/L;
  • hemoglobin ≥90g/L;
  • bilirubin of <1.5×upper limit of normal [ULN];
  • alanine aminotransferase and aspartate aminotransferase of <2.5×ULN;
  • serum creatinine of ≤1.5×ULN;
  • creatinine clearance of >50 mL/min;
  • TSH ≤1×ULN (if abnormal, T3 and T4 levels should be inspected at the same time, if T3 and T4 levels are normal, they can be included in the group);
  • APTT ≤1.5×ULN and INR ≤1.5×ULN;
  • myocardial enzymogram ≤1×ULN.
  • Written (signed) informed consent;
  • Good compliance with the study procedures, including examination and treatment;
  • Surgeons should have experience doing this type of surgery (>50 procedures per year);
  • Patients have recovered from the operation and have no unresolved postoperative complications (such as postoperative infection, anastomotic leakage, gastrointestinal bleeding, pancreatic leakage) during baseline evaluation;
  • Start first treatment between 4 weeks and 12 weeks after surgery and there is no potential disease recurrence at the baseline evaluation;
  • The serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group for the female patients of non-surgical sterilization or childbearing age;
  • During the study treatment period and within 3 months after the end of the study treatment period, a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom) should be used for the enrolled patients.

Who cannot join

  • Distant metastatic disease evaluated by Chest-abdomen-pelvis CT, bone scan and head MR when with central nervous system symptoms or PET-CT;
  • R1 or R2 surgical margins;
  • Hospital stays exceeding 60 days;
  • Patients with history of prior or concurrent malignant tumors. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible;
  • Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials);
  • Patients with serious complications such as:
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  • Uncontrolled cardiovascular disease, angina and arrhythmia;
  • Myocardial infarction in past six months;
  • Uncontrolled diabetes mellitus.
  • History of receiving anti-PD-1, anti-PD-L1, anti-PD-L2 or any other T cell co-simulation or checkpoint inhibitor therapy (eg. CTLA-4, OX-40, CD137);
  • Received any anti-cancer for this disease, including chemotherapy or radiotherapy or immunotherapy or Chinese traditional herb therapy;
  • Refuse to provide blood/tissue sample;
  • Female patients who are pregnant or lactating, or planning to become pregnant or lactating;
  • Active autoimmune disease or history of refractory autoimmune disease; Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
  • Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;
  • Uncontrollable pleural effusion, pericardial effusion or ascites;
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • Patients with history of hypersensitivity to any drugs in this study;
  • It may affect the absorption of S-1 in patients with upper gastrointestinal obstruction /bleeding, abnormal digestive function or malabsorption syndrome;
  • Have not fully recovered from toxicity or complications caused by any intervention before starting treatment;
  • HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time).
  • Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period;
  • Severe or uncontrolled systemic disease:
  • severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ level II, uncontrolled arrhythmia and myocardial infarction within 12 months before admission;
  • active infection which requires systemic treatment;
  • active tuberculosis;
  • central nervous system (CNS) disorder or peripheral nervous system disorder or psychiatric disease;
  • history of primary immunodeficiency;
  • complicated with severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury.
  • Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers.

Trial locations and contacts

1 site in 1 country.

Zhenglun Zhu contact

+86-13795409982

big8424@126.com

Min Shi contact

+86-13512118830

shimin0412005@126.com

China1 site, 1 recruiting

  • Department of Surgery, Ruijin Hospital

    Shanghai, 200025

    Jun Zhang, MD & Ph. D, +86-13818332497, junzhang10977@sjtu.edu.cn

    Zhenglun Zhu, +86-13795409982, big8424@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II, Single-center, Single-arm, Open-label Study of Nanoparticle Albumin-bound-paclitaxel (Nab-PTX) Plus S-1 and Sintilimab as Adjuvant Therapy in Patients With Stage IIIC Gastric Cancer

In this study, we combine Nab-PTX, S-1 and sintilimab as adjuvant regimen to patients with stage IIIC GC. We are aiming to investigate the recommended dose of this regimen in a phase I study and estimate the toxicity and efficacy of this regimen in a phase II study.

Read the detailed description

The phase I study is a dose-escalation study using a standard 3+3 design. The regimen involves 3-week cycles with escalated doses of nab-paclitaxel (80-120 mg/m2 on days 1 and 8) and fixed doses of sintilimab (200 mg on day 1) and S-1 (based on body-surface area on day 1 to 14). The primary endpoints are safety and determination the recommended dose in the subsequent phase II study. In the phase II trial, the primary endpoint is 3-year relapse-free survival (RFS). Secondary endpoints are 5-year overall survival (OS), 3-year OS, 5-year RFS, and quality of life. Exploratory endpoint is time to peritoneal metastasis. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.

Being tested
Nab-PTX, Sintilimab, 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.

  • Nab-PTX, Sintilimab, S-1Drug

    This is a single-arm study with all patients receiving these three drugs.

Study groups in NCT04781413
Study groupRoleWhat they receive
ExperimentalExperimentalThe phase I trial is a dose escalation design with standard 3+3 followed by expansion cohorts. Level Nab-PTX S-1 Sintilimab 1. 80 mg/m2 80mg/m2 200mg 2. 100 mg/m2 80mg/m2 200mg 3. 120 mg/m2 80mg/m2 200mg We start at level 1. The recommended dose (RD) is defined as dose equal to the maximum tolerated dose (MTD). If 1 of three patients experiences dose-limiting toxicities (DLT), three more patients will be enrolled at the same dose level. The MTD is defined as the dose level at which two or more of three patients, or at least two of 4-6 patients, have DLTs during one cycle.
Receives: Drug: Nab-PTX, Sintilimab, S-1

What is being measured

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

  1. 3-year relapse-free survival (RFS)

    Measured: 36 months

Secondary outcomes (4)

  1. 5-year overall survival (OS)

    Measured: 60 months

  2. 5-year relapse-free survival (RFS)

    Measured: 60 months

  3. Adverse events

    (based on Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)

    Measured: 36 months

  4. Peritoneal metastasis rate

    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 posted4 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Mar 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781413
Sponsor's protocol ID
DRAGON-VII
Status last verified
Mar 2021
First submitted
28 Feb 2021
Last updated
4 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mei Y, Shi M, Zhu Z, Yuan H, Yan C, Li C, Feng T, Yan M, Zhang J, Zhu Z. Addition of sintilimab to nanoparticle albumin-bound paclitaxel and S-1 as adjuvant therapy in stage IIIC gastric cancer. Future Oncol. 2022 Jan;18(2):139-148. doi: 10.2217/fon-2021-1020. Epub 2021 Dec 8.

    PubMed 34877867

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nab-PTX, Sintilimab, S-1 in people with Stage IIIC 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 24 inclusion and 30 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 4 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Zhenglun Zhu (+86-13795409982, big8424@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year relapse-free survival (RFS) (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 NCT04781413, which also lists 1 linked publication.

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 4 Mar 2021.

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