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Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer

Primary Purpose

Advanced Gastric Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Camrelizumab, Albumin-bound paclitaxel, S-1
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-75 years old, no gender limit.
  2. ECOG 0-1; estimated survival time ≥12 weeks.
  3. Histopathologically confirmed unresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma.
  4. At least one measurable lesion (RECIST1.1 standard).
  5. Have not received systemic treatment for inoperable or metastatic gastric adenocarcinoma, past (new) adjuvant chemotherapy and adjuvant radiotherapy treatment ended to enrollment> 6 months.
  6. For local lesions (non-target lesions) palliative treatment (mainly local radiotherapy) end time to random entry time> 2 weeks.
  7. The main organs and bone marrow function are basically normal:

    1. Routine blood: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥80g/L;
    2. Liver function: TBiL≤1.5×ULN; ALT/AST≤2.5×ULN (for patients with liver metastases, ≤5ULN);
    3. Renal function: serum creatinine≤1.5×ULN and creatinine clearance rate>60mL/min;
    4. INR≤1.5×ULN and activated partial thromboplastin time ≤1.5×ULN.
  8. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
  9. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.

Exclusion Criteria:

  1. Patients with symptomatic central nervous system disease or meningeal metastasis; for patients with brain metastases who have received previous treatment, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks before the first treatment, they can be considered for inclusion.
  2. Patients who have previously been treated with albumin-bound paclitaxel or paclitaxel.
  3. Received major surgery (craniotomy, thoracotomy or laparotomy), open biopsy or major traumatic injury within 28 days before enrollment, or expected major surgery during the study treatment period.
  4. Suffered from other malignant tumors in the past 5 years (except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ such as cervix and breast).
  5. The investigator believes that it will affect the subjects' ability to receive the treatment of the study protocol and are not controlled for serious medical diseases, such as combined serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Active peptic ulcer, severe infection, etc.
  6. Symptomatic congestive heart failure or cardiac color Doppler ultrasound examination shows LVEF (left ventricular ejection fraction <50%).
  7. Any arterial thromboembolic events, including unstable angina pectoris and cerebrovascular accidents, occurred within 6 months before being selected for treatment.
  8. A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment.
  9. Participate in other clinical trials 28 days before enrollment, unless participating in observational (non-interventional) clinical research or in the follow-up phase of interventional research.
  10. Patients with a history of interstitial lung disease, non-infectious pneumonia, or active tuberculosis.
  11. Patients with congenital or acquired immune deficiency, active hepatitis B or C.
  12. The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes. Those who are still using it within 2 weeks before enrollment.
  13. Patients with difficult-to-control effusion, accompanied by severe pleural effusion, abdominal effusion and other clinical symptoms.
  14. Patients with grade ≥ 2 sensory or motor neuropathy; patients with peripheral neuropathy NCT-CTCAE ≥ 2.
  15. People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders.

Sites / Locations

  • Henan Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

camrelizumab+albumin-bound paclitaxel+S-1

Arm Description

camrelizumab+albumin-bound paclitaxel+S-1

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
Defined as the proportion of patients with a documented complete response, and partial response (CR+PR).

Secondary Outcome Measures

Disease control rate (DcR)
defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD).
Overall survival (OS)
Defined as the date from random grouping to death from any cause.
Progression free survival (PFS)
Defined as the time betwween the onset of treatment and the observation of disease progression or death from any cause.

Full Information

First Posted
December 14, 2020
Last Updated
April 14, 2022
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04675866
Brief Title
Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer
Official Title
A Phase II Clinical Study of Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the First-line Treatment of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer, and to further explore the curative effect of PD - L1 expression in tumor tissue, EBV virus content, microsatellite instability (MSI), DNA mismatch repair (MMR), tumor mutation load (TMB), lymphocyte subgroup and cytokines.
Detailed Description
Gastric cancer is a common malignant tumor of digestive tract.The incidence of gastric cancer in China accounts for about half of the world's total, the incidence rate ranks second, and the mortality rate ranks second.Moreover, the proportion of early gastric cancer in China is very low, only about 20%. Most of them are in advanced stage at the time of discovery. The overall 5-year survival rate is less than 15%, which seriously threatens the health and life of Chinese people.For nearly 90% of HER2 negative patients with advanced gastric and gastroesophageal junction adenocarcinoma (g / GEJ), the current first-line treatment option is chemotherapy, and the efficacy of available drugs is very limited.The ORR of the first-line chemotherapy is about 40%, and the OS is about 10 months. New therapeutic drugs are urgently needed to improve the efficacy of advanced G/GEJ.The purpose of this study was to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
camrelizumab+albumin-bound paclitaxel+S-1
Arm Type
Experimental
Arm Description
camrelizumab+albumin-bound paclitaxel+S-1
Intervention Type
Other
Intervention Name(s)
Camrelizumab, Albumin-bound paclitaxel, S-1
Intervention Description
Camrelizumab: 200mg, iv, Q3W, d1; Albumin-bound paclitaxel: 125mg/m2, iv, d1, 8, Q3W; S-1: According to the patient's body surface area, the dosage is set to 40, 50, 60 mg/time, bid, po, taking 2 weeks, and stopping the drug for 1 week as a cycle.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Defined as the proportion of patients with a documented complete response, and partial response (CR+PR).
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Disease control rate (DcR)
Description
defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD).
Time Frame
up to 2 years
Title
Overall survival (OS)
Description
Defined as the date from random grouping to death from any cause.
Time Frame
up to 2 years
Title
Progression free survival (PFS)
Description
Defined as the time betwween the onset of treatment and the observation of disease progression or death from any cause.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years old, no gender limit. ECOG 0-1; estimated survival time ≥12 weeks. Histopathologically confirmed unresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma. At least one measurable lesion (RECIST1.1 standard). Have not received systemic treatment for inoperable or metastatic gastric adenocarcinoma, past (new) adjuvant chemotherapy and adjuvant radiotherapy treatment ended to enrollment> 6 months. For local lesions (non-target lesions) palliative treatment (mainly local radiotherapy) end time to random entry time> 2 weeks. The main organs and bone marrow function are basically normal: Routine blood: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥80g/L; Liver function: TBiL≤1.5×ULN; ALT/AST≤2.5×ULN (for patients with liver metastases, ≤5ULN); Renal function: serum creatinine≤1.5×ULN and creatinine clearance rate>60mL/min; INR≤1.5×ULN and activated partial thromboplastin time ≤1.5×ULN. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period. Exclusion Criteria: Patients with symptomatic central nervous system disease or meningeal metastasis; for patients with brain metastases who have received previous treatment, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks before the first treatment, they can be considered for inclusion. Patients who have previously been treated with albumin-bound paclitaxel or paclitaxel. Received major surgery (craniotomy, thoracotomy or laparotomy), open biopsy or major traumatic injury within 28 days before enrollment, or expected major surgery during the study treatment period. Suffered from other malignant tumors in the past 5 years (except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ such as cervix and breast). The investigator believes that it will affect the subjects' ability to receive the treatment of the study protocol and are not controlled for serious medical diseases, such as combined serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Active peptic ulcer, severe infection, etc. Symptomatic congestive heart failure or cardiac color Doppler ultrasound examination shows LVEF (left ventricular ejection fraction <50%). Any arterial thromboembolic events, including unstable angina pectoris and cerebrovascular accidents, occurred within 6 months before being selected for treatment. A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment. Participate in other clinical trials 28 days before enrollment, unless participating in observational (non-interventional) clinical research or in the follow-up phase of interventional research. Patients with a history of interstitial lung disease, non-infectious pneumonia, or active tuberculosis. Patients with congenital or acquired immune deficiency, active hepatitis B or C. The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes. Those who are still using it within 2 weeks before enrollment. Patients with difficult-to-control effusion, accompanied by severe pleural effusion, abdominal effusion and other clinical symptoms. Patients with grade ≥ 2 sensory or motor neuropathy; patients with peripheral neuropathy NCT-CTCAE ≥ 2. People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders.
Facility Information:
Facility Name
Henan Tumor Hospital
City
Ho-nan
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hou xinfang Hou, Doctor
Phone
15136130286
Email
929700390@qq.com

12. IPD Sharing Statement

Learn more about this trial

Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer

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