NCT05225844

Brief Summary

At present, surgery, radiotherapy and chemotherapy are the main treatment methods for patients with advanced gastrointestinal cancer. Although targeted therapy has significantly improved the prognosis of patients, the mortality of patients has not been significantly reduced, so new treatment methods are urgently needed. In recent years, immunotherapy has become a new hotspot in tumor therapy. Compared with traditional treatment, immune checkpoint inhibitors (ICIS) have shown long-term good efficacy and tolerance in clinical trials. However, single drug ICIS has reached a bottleneck for advanced gastrointestinal cancer, with low response rate and poor PFS and OS. With the results of REGONIVO showing good efficacy, the treatment mode of immune combined with small molecule anti angiogenesis drugs has sprung up. The purpose of this study was to analyze the efficacy and safety of in Camrelizumab combination with Apatinib mesylate in advanced gastrointestinal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

3.1 years

First QC Date

January 24, 2022

Last Update Submit

February 4, 2022

Conditions

Gastrointestinal CancerImmunotherapyTargeted Therapy

Outcome Measures

Primary Outcomes (2)

  • Objective response rate (ORR)

    The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.

    24 months

  • progression-free survival（PFS）

    the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)

    24 months

Secondary Outcomes (3)

  • Overall Survival（OS）

    24 months

  • Adverse Events

    24 months

  • Disease control rate(DCR)

    24 months

Study Arms (2)

Camrelizumab Plus Apatinib mesylate

EXPERIMENTAL

for advanced gastric cancer with previous standard treatment failure

Drug: CamrelizumabDrug: Apatinib Mesylate

Camrelizumab and Apatinib mesylate

EXPERIMENTAL

for advanced colorectal cancer with previous standard treatment failure

Drug: CamrelizumabDrug: Apatinib Mesylate

Interventions

CamrelizumabDRUG

Camrelizumab ，200mg/㎡，d1，ivgtt，every 21 days as a cycle

Camrelizumab Plus Apatinib mesylateCamrelizumab and Apatinib mesylate
Apatinib MesylateDRUG

Apatinib Mesylate，250mg/㎡，po，d1-5 on/d2 off，every 21 days as a cycle

Camrelizumab Plus Apatinib mesylateCamrelizumab and Apatinib mesylate

Eligibility Criteria

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

You may qualify if:

  • \. Diagnosed as gastric or colorectal adenocarcinoma by histopathology and/or cytology.
  • \. Patients could not receive surgical resection. 3. Previous standard treatment failure . 4. According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
  • Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score 6.The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).
  • Hemoglobin(HB)≥90g/L;
  • Absolute neutrophil count (ANC) ≥1.5×10\^9/L;
  • Blood platelet (PLT)≥80×10\^9/L; (2) Biochemical examination should comply with the following criteria:
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  • Bilirubin(BIL) \<1.5 times of the upper limit of normal value (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase(AST)\<2.5\*ULN (liver metastasis ALT and AST\<5\*ULN).
  • Serum Cr≤1\*ULN, creatinine clearance rate≥50ml/min(Cockcroft-Gault formula) 7. The expected survival time more than 3 months; 8. The physicians plan to use Camrelizumab Plus Apatinib Mesylate. 9. Patients voluntarily joined the study and signed informed consent form(ICF). 10. Childbearing age women must undergo a negative pregnancy test(serum or urine) within 7 days ,and voluntarily adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug;As for men, it is necessary to receive surgical sterilization, or agree to adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug.

You may not qualify if:

  • There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
  • Acute coronary artery syndrome
  • Acute heart failure (grade III or IV of NYHA classification)
  • Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation).
  • (2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months.
  • (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
  • There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
  • ECOG score≥2
  • Abnormal coagulation function (INR\>1.5\*ULN, Activated Partial Thromboplastin Time (APTT)\>1.5\*ULN), with bleeding tendency.
  • There is any history of allergy or hypersensitivity in this research's drug or adjuvant.
  • HIV infection and/or active hepatitis B virus infection.
  • Any condition that may damage the safety of patients or the integrity of research data, including serious medical risk factors, physical condition and laboratory abnormality.
  • Pregnant or lactating women;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

camrelizumabapatinib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Yu Han, doctor

CONTACT

+86-451-86298303hanyuemail@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 7, 2022

Study Start

January 1, 2019

Primary Completion

February 1, 2022

Study Completion

October 1, 2022

Last Updated

February 7, 2022

Record last verified: 2022-02

Locations

CN(1)