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Gastric Cancer Stage IIIPhase 2NCT04515615

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

A Phase 2 study testing Camrelizumab, Oxaliplatin and Tegafur gimeracil oteracil potassium capsule in people with Gastric Cancer Stage III, run by Yu jiren at 4 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer Stage III
What is being tested?
Camrelizumab, Oxaliplatin and Tegafur gimeracil oteracil potassium capsule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
4 sitesChina
Study dates
9 Sep 2020to 29 Mar 2026
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

  • 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).
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  • 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):
  • 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.
  • Hepatic function：
  • Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal);
  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN;
  • Albumin (ALB) ≥ 30 g / L.
  • Renal function：
  • Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml / min for those with creatinine level > 1.5 × ULN.
  • Coagulation function：
  • International normalized ratio (INR) ≤ 1.5;
  • Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • Female of childbearing age must meet requirements: urine pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of camrelizumab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of camrelizumab, or 180 days after the last dose of chemotherapy, whichever is longer).

Who cannot join

  • 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.
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  • 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.
  • Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.
  • Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

  • Taizhou Hospital

    Taizhou, Zhejiang, 317000

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325027

Other trials in China

About this study

Official title: A Multi-center, Phase II Study to Evaluate Safety and Efficacy of Adjuvant Chemotherapy With Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin and Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

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.

Read the detailed description
  1. Study population: participants with stage III gastric cancer confirmed by postoperative pathology according to American Joint Committee on Cancer (AJCC) / Union for International Cancer Control (UICC) 8th Tumor Node Metastasis (TNM) staging classification.
  2. Sample size: single arm design was used in this study and 52 participants were estimated to be enrolled.
  3. Research content: In this study, within 4-6 weeks after the completion of the operation, the participants were selected and qualified for this study, and were scheduled to receive 200mg camrelizumab once intravenous infusion on the first day (q3w), then 130mg/m^2 oxaliplatin on the first day (q3w), and tegafur gimeracil oteracil potassium capsule was taken as follow: surface area is less than 1.25, 80mg per day, twice a day; ≥1.25 ~ <1.5, 100mg per day, twice a day; ≥1.5, 120mg per day, twice a day, and oral administration for 1-14 days every 3 weeks. Three weeks as a course of treatment, a total of 8 courses, after treatment, safety visit and survival follow-up will be carried out. A total of 3 years follow-up time is scheduled since the first medication, and the frequency is once every 3-6 months within 2 years, and once every 6-12 months for the third year.
  4. Adverse events (AEs) management: To minimize the risk of AEs, the investigators will monitor carefully to determine whether or not they are within the expected range. The degree of AEs is evaluated according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.0). Investigators will also conduct a thorough examination and adopt an appropriate system to take any necessary measures to deal with AEs.
Being tested
Camrelizumab, Oxaliplatin, Tegafur gimeracil oteracil potassium capsule
Keywords
Gastric cancer, Camrelizumab, Chemotherapy, Phase II
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Also called SHR-1210

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

  • OxaliplatinDrug

    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.

  • Tegafur gimeracil oteracil potassium capsuleDrug

    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.

Study groups in NCT04515615
Study groupRoleWhat they receive
Camrelizumab and chemotherapyExperimentalParticipants 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.
Receives: Drug: Camrelizumab; Drug: Oxaliplatin; Drug: Tegafur gimeracil oteracil potassium capsule

What is being measured

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

  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.

    Measured: 9 months

Secondary outcomes (3)

  1. Disease-free survival (DFS)

    Disease-free survival (DFS)

    Measured: 3 years

  2. Overall survival (OS)

    Overall survival (OS)

    Measured: 3 years

  3. Treatment completion rate

    Percentage of participants who complete eight cycles of chemotherapy in combination with Camrelizumab.

    Measured: 6 months

Timeline

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

  1. First posted17 Aug 2020
  2. Study start9 Sep 2020
  3. Primary completion29 Dec 2023
  4. Study completion29 Mar 2026 (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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04515615
Sponsor's protocol ID
IIT20200046C-R1
Status last verified
Sep 2024
First submitted
14 Aug 2020
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40656603

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Oxaliplatin and Tegafur gimeracil oteracil potassium capsule in people with Gastric Cancer Stage III, run by Yu jiren at 4 sites 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 25 inclusion and 17 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidences and types of adverse events (time frame: 9 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 NCT04515615, 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 19 Sep 2024.

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