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

NCT04781413 | Unknown Phase 1 DMC

• 1 other identifier: DRAGON-VII
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage IIIC Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year relapse-free survival (RFS)

  36 months

Secondary Outcomes (4)

• 5-year overall survival (OS)

  60 months

• 5-year relapse-free survival (RFS)

  60 months

• Adverse events

  36 months

• Peritoneal metastasis rate

  36 months

Study Arms (1)

Experimental

EXPERIMENTAL

The 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.

Drug: Nab-PTX, Sintilimab, S-1

Interventions

Nab-PTX, Sintilimab, S-1 DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);

You may not qualify if:

• 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:
• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Surgery, Ruijin Hospital

Shanghai, 200025, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34877867 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zhenggang Zhu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Jun Zhang

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenglun Zhu

CONTACT

+86-13795409982; big8424@126.com

Min Shi

CONTACT

+86-13512118830; shimin0412005@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Oncology

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)