Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

NCT04515615 | Active Not Recruiting Phase 2

• 1 other identifier: IIT20200046C-R1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the safety of tegafur gimeracil oteracil potassium capsule plus oxaliplatin and Camrelizumab as adjuvant therapy in stage III gastric cancer, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), overall survival (OS) and treatment completion rate.

Conditions

Gastric Cancer Stage III

Keywords

Gastric cancer; Camrelizumab; Chemotherapy; Phase II

Outcome Measures

Primary Outcomes (1)

• The incidences and types of adverse events

  The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

  9 months

Secondary Outcomes (3)

• Disease-free survival (DFS)

  3 years

• Overall survival (OS)

  3 years

• Treatment completion rate

  6 months

Study Arms (1)

Camrelizumab and chemotherapy

EXPERIMENTAL

Participants receive camrelizumab 200 mg intravenously (IV) on the first day (q3w), then oxaliplatin 130 mg/m\^2, IV on the first day (q3w), and tegafur gimeracil oteracil potassium capsule 80 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Three weeks as a course of treatment, a total of 8 courses.

Drug: Camrelizumab; Drug: Oxaliplatin; Drug: Tegafur gimeracil oteracil potassium capsule

Interventions

Camrelizumab DRUG

Camrelizumab, 200 mg IV for 30-60 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.

Also known as: SHR-1210

Camrelizumab and chemotherapy

Oxaliplatin DRUG

Oxaliplatin: 130 mg/m\^2 IV for 2-6 hour in first day which will be administered at least 30 min after completion of camrelizumab administration, every 3 weeks. Repeated every 21 days, 21 days for a cycle.

Camrelizumab and chemotherapy

Tegafur gimeracil oteracil potassium capsule DRUG

Tegafur gimeracil oteracil potassium capsule: 80 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Repeated every 21 days. 21 days for a cycle.

Camrelizumab and chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
• The gender is not limited. Age: ≥ 18 years and ≤ 75 years old.
• Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology.
• Without evidence of distant metastatic disease before operation by imaging.
• Received D2 or D2+ radical gastrectomy by open surgery (R0 resection).
• Stage III gastric cancer confirmed by postoperative pathology (AJCC/UICC 8th TNM staging classification).
• Participants with a performance status of 0 \~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.
• Life expectancy ≥ 6 months.
• The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of blood transfusion, albumin, recombinant human thrombopoietin or granulocyte stimulating factor):
• A. Hematological function：
• White blood cell count (WBC): 3.5 × 10 \^ 9 / L \~12.0 × 10 \^ 9 / L；
• Absolute neutrophil count (ANC) ≥ 1.5 × 10 \^ 9 / L；
• Platelet count (PLT) ≥ 100 × 10 \^ 9 / L；
• Hemoglobin (Hb) ≥ 90 g / L.
• B. Hepatic function：

You may not qualify if:

• Received previous chemotherapy, radiotherapy, targeted therapy or immunotherapy.
• Previous or concurrent have other active malignant tumors (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).
• Existence of unrecovered complications after radical gastrectomy before the first dose of study treatment (including but not limited to: infection, gastrointestinal bleeding/ obstruction, anastomotic fistula, pancreatic fistula and anastomotic stenosis).
• Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV), echocardiogram shows left ventricular ejection fraction (LVEF) \< 50%.
• Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).
• Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.
• Participants with active tuberculosis.
• Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.
• Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.
• Females who are pregnant or breastfeeding or expecting to conceive during the study period.
• Participants who need long-term systemic steroid therapy (\> 10 mg/d prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.
• Concurrent or previous have severe allergic reaction to any antibody-based drugs.
• Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia).
• Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

Sponsors & Collaborators

• Yu jiren: lead

Study Sites (4)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

Location

Taizhou Hospital

Taizhou, Zhejiang, 317000, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (1)

• Jin H, Yu J, Gao Y, Liu X, Xu H, Jiang H, Zhou S, Xu N, Zheng Y, Shen Q, Zhao Z, Wu D, Zhang Q, Zhu K. Camrelizumab plus SOX chemotherapy as adjuvant therapy for pathological stage III gastric or gastroesophageal junction adenocarcinoma: a prospective, multicenter, single-arm, phase II trial. Ther Adv Med Oncol. 2025 Jul 10;17:17588359251355781. doi: 10.1177/17588359251355781. eCollection 2025.

  PMID: 40656603 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Jiren Yu

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 17, 2020
• Study Start: September 9, 2020
• Primary Completion: December 29, 2023
• Study Completion: March 29, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (4)