A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

NCT04152889 | Unknown Phase 2

• 1 other identifier: ZG IIIS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To evaluate the safety ofCamrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). Objective: To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer.

Conditions

Gastric Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• DFS

  disease-free survival

  1YEARS

Study Arms (1)

Camrelizumab+chemotherapy

EXPERIMENTAL

Drug: Camrelizumab; Drug: S-1; Drug: Docetaxel

Interventions

Camrelizumab DRUG

Camrelizumab, 200 mg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.

Also known as: SHR-1210

Camrelizumab+chemotherapy

S-1 DRUG

Tegafur-gimeracil-oteracil potassium: 80 - 120 mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle.

Camrelizumab+chemotherapy

Docetaxel DRUG

Docetaxel: 40 mg/m\^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle.

Camrelizumab+chemotherapy

Eligibility Criteria

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

You may qualify if:

• The patients voluntarily joined the study and signed the informed consent;
• ≥ 18 years old, ≥ 80 years old, both male and female;
• Stage III gastric cancer confirmed by pathology,
• ECoG score: 0-1
• Detection of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS ≥ 10% / MSI-H + / EBV+/dMMR
• No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment
• 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 female patients of non-surgical sterilization or childbearing age; the serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group; and the hCG test must be non lactation; for the male patients Sex, should be surgical sterilization, or agree to use appropriate methods of contraception during the trial and within 3 months after the last administration of the test drug.
• The baseline blood routine and biochemical indexes of the selected patients should meet the following standards:
• A. hemoglobin ≥ 90g / L
• B. absolute neutrophil count ≥ 1.5 × 10 \^ 9 / L
• C. platelet count ≥ 100 × 10 \^ 9 / L
• D. ASTor ALT ≤ 2.5 ULN
• E. Alkaline phosphatase (ALP)≤ 2.5×ULN
• TSH ≤ 1 ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group);

You may not qualify if:

• Pregnant or lactating women;
• Women of childbearing age were positive in the baseline pregnancy test;
• Distant metastasis was diagnosed by CT /MR/ EUS.
• Received previous anti-tumor treatment, including chemotherapy, radiotherapy or immunotherapy;
• Have other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer);
• Uncontrollable pleural effusion, pericardial effusion or ascites;
• Severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ level II, uncontrolled arrhythmia and myocardial infarction within 12 months before admission;
• With gastroduodenal obstruction/bleeding, digestive dysfunction or malabsorption syndrome
• Complicated with severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury;
• Allergic reaction to the drugs used in this study;
• Steroid or other systemic immunosuppressive therapy was used 14 days before admission;
• Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials).
• Active autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected.
• History of primary immunodeficiency.
• Immunosuppressive drugs were used within 4 weeks prior to the first dose of study treatment, excluding local or physiological doses of systemic glucocorticoids (i.e. 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

• RenJi Hospital: lead

Study Sites (1)

Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; S 1 (combination); Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Gang Zhao

  RenJi Hospital, Shanghai JiaoTong University, School of Medicine Shanghai, Shanghai, China, 200127

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Zhao

CONTACT

0086-021-68383731; zhaogang74313@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of gastrointestinal surgery administration

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 5, 2019
• Study Start: April 14, 2020
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

CN (1)