NCT05524974

Brief Summary

To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for phase_2

Timeline
16mo left

Started Sep 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2022Sep 2027

First Submitted

Initial submission to the registry

August 10, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 10, 2022

Last Update Submit

August 30, 2022

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    4 months

Secondary Outcomes (8)

  • R0 resection rate

    4 months

  • Disease control rate

    4 months

  • 1-year and 3-year OS/DFS

    1 and 3 years

  • adverse event

    3 years

  • overall postoperative morbidity rates

    30 days

  • +3 more secondary outcomes

Study Arms (7)

Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes

EXPERIMENTAL
Drug: CamrelizumabDrug: OxaliplatinDrug: S1

Oxplatin and S-1 for Immune Genotypes

ACTIVE COMPARATOR
Drug: OxaliplatinDrug: S1

Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes

EXPERIMENTAL
Drug: OxaliplatinDrug: S1Drug: Apatinib Mesylate

Oxplatin and S-1 for Mesenchymal Genotypes

ACTIVE COMPARATOR
Drug: OxaliplatinDrug: S1

Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes

EXPERIMENTAL
Drug: OxaliplatinDrug: S1Drug: Nab paclitaxel

Oxplatin and S-1 for Classic Genotypes

ACTIVE COMPARATOR
Drug: OxaliplatinDrug: S1

Oxplatin and S-1 for Metabolic Genotypes

ACTIVE COMPARATOR
Drug: OxaliplatinDrug: S1

Interventions

CamrelizumabDRUG

Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.

Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
OxaliplatinDRUG

Oxaliplatin for Injection 135mg/m2 /per day，ivgtt，in day1. Given once every 3 weeks.

Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal GenotypesCamrelizumab combined with Oxplatin and S-1 for Immune GenotypesNab-paclitaxel combined with Oxplatin and S-1 for Classic GenotypesOxplatin and S-1 for Classic GenotypesOxplatin and S-1 for Immune GenotypesOxplatin and S-1 for Mesenchymal GenotypesOxplatin and S-1 for Metabolic Genotypes
S1DRUG

S-1 was calculated according to body surface area , P.O., bid, d1-d14. And the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time

Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal GenotypesCamrelizumab combined with Oxplatin and S-1 for Immune GenotypesNab-paclitaxel combined with Oxplatin and S-1 for Classic GenotypesOxplatin and S-1 for Classic GenotypesOxplatin and S-1 for Immune GenotypesOxplatin and S-1 for Mesenchymal GenotypesOxplatin and S-1 for Metabolic Genotypes
Apatinib MesylateDRUG

Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday.

Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
Nab paclitaxelDRUG

nab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260 mg/m2 in day 1 and day 8.

Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 75 years, all sex；
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology；
  • CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.；
  • measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter of lymph node≥15mm，scan slice thickness 5mm）;
  • ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores;
  • the expected survival time is more than 12 weeks;
  • the main organ function is normal, which should meet the following criteria: （1）(1)blood routine examination standards should be met（no blood transfusion within 14 days）
  • HB≥100g/L，
  • WBC≥3×109/L
  • ANC≥1.5×109/L，
  • PLT≥100×109/L； （2）biochemical examination shall comply with the following criteria：
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  • BIL \<1.5normal upper limit（ULN），
  • ALT和AST\<2.5ULN，GPT≤1.5×ULN；
  • serum Cr≤1ULN，creatinine clearance rate\>60ml/min（Cockcroft-Gault formula）
  • +2 more criteria

You may not qualify if:

  • Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy
  • Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for major abdominal surgery；
  • patients with metastasis；
  • Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin；
  • A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation；
  • Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection；
  • pregnant or lactating women；
  • The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure \>140 mmHg, diastolic pressure \>90 mmHg)；
  • With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male \> 450 ms, women \> 470 ms) and cardiac insufficiency；
  • Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and coagulation dysfunction (INR(international normalized ratio)\>1.5, APTT(activated partial thromboplastin time)\>1.5 ULN), with bleeding tendency;；
  • Subjects have failed to control good cardiovascular clinical symptoms or disease, including but not limited to: such as: (1) the NYHA class II heart failure or above (2) unstable angina pectoris (3) MI occurred within 1 year (4) have clinical significance of supraventricular or ventricular arrhythmias without clinical intervention on or after clinical intervention is still poorly controlled；
  • History of interstitial lung disease (except radiation pneumonia without hormone therapy), and history of non-infectious pneumonia；
  • Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative \>1.0g)；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Interventions

camrelizumabOxaliplatinS 1 (combination)apatinibTaxes

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsEconomicsHealth Care Economics and Organizations

Study Officials

  • Chang-Ming Huang, phD

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Ming Huang, PhD

CONTACT

8613805069676hcmlr2002@163.com

Hualong Zheng, PhD

CONTACT

18359190587291167038@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of gastric surgery

Study Record Dates

First Submitted

August 10, 2022

First Posted

September 1, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2024

Study Completion (Estimated)

September 1, 2027

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

CN(1)