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Immunotherapy Versus Chemotherapy as Adjuvant Therapy for Colon Cancer With MSI-H or POLE/ POLD1 Mutations

Primary Purpose

Immunotherapy, Adjuvant Therapy, Colon Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tirelizumab

About this trial

This is an interventional treatment trial for Immunotherapy

Eligibility Criteria

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

Inclusion Criteria:

Signed the informed consent.
Age ≥18.
Colonic adenocarcinoma confirmed histologically or histopathologically.
No residual cancer was confirmed after radical resection of colon cancer.
According to the overall postoperative results, T4NX/TXN+ colon cancer was determined according to AJCC/ UICC TNM staging eighth edition.
No liver, peritoneum or other distant metastases.
MSI-H or POLE/ POLD1 gene mutation was confirmed by PRC or NGS sequencing.
ECOG physical status score is 0 or 1.
Appropriate organ function according to the following laboratory test values obtained within 7 days prior to use on Day 1 of Cycle 1:
A. Hemoglobin value ≥9.0g/dL. B. Absolute neutrophil count ≥1,500/mm3 (≥1.5*109/L). C. Platelet count ≥100,000/mm3 (≥100*109/L). D. Total serum bilirubin ≤1.5* upper normal limit (ULN). E. aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5* upper limit of normal value (ULN).
F. Serum creatinine ≤1.5 times * upper limit of normal (ULN) or creatinine clearance ≥50ml/min.
Willing and able to follow research procedures and visit plans.

Exclusion Criteria:

The patient had received non-surgical treatment for colon cancer (e.g., radiation, chemotherapy, and hormone therapy).
Has a serious illness or medical condition, including but not limited to the following:
A. Recurrent in situ or metastatic tumor of any other site is known. B. Systemic active infection (i.e., infection causes body temperature ≥38℃). C. Clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease.
D. Severe/unstable angina, New York Heart Association (NYHA) grade III or IV symptomatic congestive heart failure.
E. Gastrointestinal bleeding of clinical significance. F. Known presence of human immunodeficiency virus (HIV) or acquired routine immunodeficiency syndrome (AIDS) -associated disease, or active hepatitis B or C.
Pregnant or lactating women.
The researcher did not consider it appropriate to enter the study.

Sites / Locations

Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

immunotherapy

chemotherapy

Arm Description

In the immunotherapy group, the treatment regimen was Tirelizumab 200mg, intravenously infused once every 3 weeks until the end of 12 months of treatment, with a total of 17 infused times.

The chemotherapy regimen of the standard chemotherapy group was XELOX regimen, oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 21 days. The duration of treatment was determined according to the patient's postoperative pathological stage (3 months for T4N0/ T1-3N1 and 6 months for T4N+/ T1-3N2).

Outcomes

Primary Outcome Measures

3-year relapse-free survival

The time from the beginning of randomization to the time when the disease recurs or the patient dies from any cause.

Secondary Outcome Measures

Full Information

NCT ID

NCT04969029

First Posted

July 5, 2021

Last Updated

July 11, 2021

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04969029

Brief Title

Immunotherapy Versus Chemotherapy as Adjuvant Therapy for Colon Cancer With MSI-H or POLE/ POLD1 Mutations

Official Title

Randomized, Controlled Phase II Study of Immunotherapy Versus Standard Chemotherapy as Adjuvant Therapy After Surgery for Colon Cancer With MSI-H or POLE/ POLD1 Mutations

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of immunotherapy versus standard chemotherapy in patients undergoing T4NX/TXN+ colon cancer surgery with MSI-H or POLE/ POLD1 mutations.This study was conducted in the Department of Gastroenterology, Tumor Hospital of Tianjin Medical University. Patients with MSI-H or POLE/ POLD1 gene mutations confirmed by PCR sequencing or NGS sequencing will be randomly assigned (2:1) to immunotherapy (experimental group) or standard chemotherapy (control group) after signing informed consent. In this study, 30 patients will be enrolled, 20 patients will receive immunotherapy and 10 patients will receive standard chemotherapy. In the immunotherapy group, the treatment regimen was Tirelizumab 200mg, intravenously infused once every 3 weeks until the end of 12 months of treatment, with a total of 17 infused times. Patients enrolled in this group could enjoy the preferential policy of purchasing 7 times and giving 10 times at their own expense. The chemotherapy regimen of the standard chemotherapy group was XELOX regimen, oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 21 days. The duration of treatment was determined according to the patient's postoperative pathological stage (3 months for T4N0/ T1-3N1 and 6 months for T4N+/ T1-3N2). Patients received regular and periodic reviews, with imaging evaluations every 3 months for the first 2 years and every 6 months after 2 years. Safety will be evaluated by AE and laboratory tests. After tumor recurrence or metastasis was first detected, tumor tissue biopsies were taken again for NGS sequencing, and all patients were followed up every 3 months until death according to the plan.

6. Conditions and Keywords

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

Immunotherapy, Adjuvant Therapy, Colon Cancer, MSI-H

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

immunotherapy

Arm Type

Experimental

Arm Description

In the immunotherapy group, the treatment regimen was Tirelizumab 200mg, intravenously infused once every 3 weeks until the end of 12 months of treatment, with a total of 17 infused times.

Arm Title

chemotherapy

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tirelizumab

Intervention Description

In the immunotherapy group, the treatment regimen was Tirelizumab 200mg, intravenously infused once every 3 weeks until the end of 12 months of treatment, with a total of 17 infused times.

Primary Outcome Measure Information:

Title

3-year relapse-free survival

Description

The time from the beginning of randomization to the time when the disease recurs or the patient dies from any cause.

Time Frame

60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed the informed consent. Age ≥18. Colonic adenocarcinoma confirmed histologically or histopathologically. No residual cancer was confirmed after radical resection of colon cancer. According to the overall postoperative results, T4NX/TXN+ colon cancer was determined according to AJCC/ UICC TNM staging eighth edition. No liver, peritoneum or other distant metastases. MSI-H or POLE/ POLD1 gene mutation was confirmed by PRC or NGS sequencing. ECOG physical status score is 0 or 1. Appropriate organ function according to the following laboratory test values obtained within 7 days prior to use on Day 1 of Cycle 1: A. Hemoglobin value ≥9.0g/dL. B. Absolute neutrophil count ≥1,500/mm3 (≥1.5*109/L). C. Platelet count ≥100,000/mm3 (≥100*109/L). D. Total serum bilirubin ≤1.5* upper normal limit (ULN). E. aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5* upper limit of normal value (ULN). F. Serum creatinine ≤1.5 times * upper limit of normal (ULN) or creatinine clearance ≥50ml/min. Willing and able to follow research procedures and visit plans. Exclusion Criteria: The patient had received non-surgical treatment for colon cancer (e.g., radiation, chemotherapy, and hormone therapy). Has a serious illness or medical condition, including but not limited to the following: A. Recurrent in situ or metastatic tumor of any other site is known. B. Systemic active infection (i.e., infection causes body temperature ≥38℃). C. Clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease. D. Severe/unstable angina, New York Heart Association (NYHA) grade III or IV symptomatic congestive heart failure. E. Gastrointestinal bleeding of clinical significance. F. Known presence of human immunodeficiency virus (HIV) or acquired routine immunodeficiency syndrome (AIDS) -associated disease, or active hepatitis B or C. Pregnant or lactating women. The researcher did not consider it appropriate to enter the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Ba, MD

Phone

022-23340123-1053

bayi999@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhi Ji, MD

Phone

022-23340123-1053

jizhikey@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Ba, MD

Organizational Affiliation

Tianjin Medical University Cancer Institute and Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Ba, MD

Phone

022-23340123-1053

bayi999@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Immunotherapy Versus Chemotherapy as Adjuvant Therapy for Colon Cancer With MSI-H or POLE/ POLD1 Mutations

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