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Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer

Primary Purpose

Rectal Cancer, Radiotherapy, Immunotherapy

Status

Active

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Chemotherapy

Immunotherapy

IMRT

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

Patients who personally provided written consent for participation in the study
Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT
Histologically confirmed adenocarcinoma of rectum (non-metastatic, >T2N0 or low T2N0 rectal cancer) not eligible for up-front organ preservation surgery as deemed by multidisciplinary evaluation
Patients with the ECOG performance status of 0 or 1 at the time of enrollment
Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy
Male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug
Patients must have acceptable organ and marrow function as defined below:

Absolute neutrophil count (ANC) >1,500/uL Hg > 8.0 g/dL; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion Platelets >100,000/uL Total bilirubin <1.5X normal institutional limits aspartate aminotransferase (AST) (SGOT) / alanine aminotransferase (ALT)(SGPT) < 3X upper limit of normal Creatinine <1.5X upper limit of normal or creatinine clearance (CrCL)>50 by Cockcroft-Gault

Exclusion Criteria:

Patients with recurrent rectal cancer or a history of pelvic radiation
Patients with a history of inflammatory bowel disease
Patients with a history of pneumonitis or interstitial lung disease
Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
Patients with a history of thyroid dysfunction
Patients with a history or finding of cardiovascular risk
Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody
Patients who are pregnant or lactating or who may be pregnant
Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study

Sites / Locations

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiotherapy, chemotherapy and PD1 inhibitor

Arm Description

Treatment will comprise 5 daily fractions of radiotherapy at 5 Gy per fraction followed by chemotherapy and immunotherapy. Those who achieve a clinical complete response will be considered for organ preservation approach. All other patients will receive standard surgery.

Outcomes

Primary Outcome Measures

Clinical complete response rate (cCR)

Proportion of patients who achieve a clinical complete response following treatment

Secondary Outcome Measures

Local regrowth rate

Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology

Disease free survival (DFS)

Five years disease-free survival of this group of patients

Overall survival (OS)

Fives years overall survival of this group of patients

Incidence of adverse events (AEs)

Incidence of adverse events will be assessed according to the latest "Clavien- Dindo Classification of surgical complications" and Common Terminology Criteria of Adverse Events (CTCAE).

Full Information

NCT ID

NCT04558684

First Posted

September 16, 2020

Last Updated

June 19, 2021

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT04558684

Brief Title

Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer

Official Title

Short Course Radiotherapy With Total Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan Union Hospital, China

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 open-label, single-arm study to investigate the safety and efficacy of Total neoadjuvant chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy in patients with rectal cancer.

Detailed Description

Patients with rectal cancer are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with total neoadjuvant chemotherapy and camrelizumab, an anti-PD-1 antibody drug. The Primary Objective is to assess clinical complete response of an organ preservation approach and the secondary objective to assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach.

6. Conditions and Keywords

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

Rectal Cancer, Radiotherapy, Immunotherapy, Organ Preservation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

radiotherapy, chemotherapy and PD1 inhibitor

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

CAPOX (6 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine: Dose of 2000mg/m2,14 days, q3w

Intervention Type

Drug

Intervention Name(s)

Immunotherapy

Intervention Description

Camrelizumab (6 cycles): 200mg on day 1 of each cycle, q3w

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

Radiotherapy (5 Gy x 5 fractions)

Primary Outcome Measure Information:

Title

Clinical complete response rate (cCR)

Description

Proportion of patients who achieve a clinical complete response following treatment

Time Frame

8 (+/-4 ) weeks

Secondary Outcome Measure Information:

Title

Local regrowth rate

Description

Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology

Time Frame

2 year

Title

Disease free survival (DFS)

Description

Five years disease-free survival of this group of patients

Time Frame

5 year

Title

Overall survival (OS)

Description

Fives years overall survival of this group of patients

Time Frame

5 year

Title

Incidence of adverse events (AEs)

Description

Incidence of adverse events will be assessed according to the latest "Clavien- Dindo Classification of surgical complications" and Common Terminology Criteria of Adverse Events (CTCAE).

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who personally provided written consent for participation in the study Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT Histologically confirmed adenocarcinoma of rectum (non-metastatic, >T2N0 or low T2N0 rectal cancer) not eligible for up-front organ preservation surgery as deemed by multidisciplinary evaluation Patients with the ECOG performance status of 0 or 1 at the time of enrollment Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy Male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug Patients must have acceptable organ and marrow function as defined below: Absolute neutrophil count (ANC) >1,500/uL Hg > 8.0 g/dL; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion Platelets >100,000/uL Total bilirubin <1.5X normal institutional limits aspartate aminotransferase (AST) (SGOT) / alanine aminotransferase (ALT)(SGPT) < 3X upper limit of normal Creatinine <1.5X upper limit of normal or creatinine clearance (CrCL)>50 by Cockcroft-Gault Exclusion Criteria: Patients with recurrent rectal cancer or a history of pelvic radiation Patients with a history of inflammatory bowel disease Patients with a history of pneumonitis or interstitial lung disease Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study Patients with a history of thyroid dysfunction Patients with a history or finding of cardiovascular risk Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody Patients who are pregnant or lactating or who may be pregnant Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study

Facility Information:

Facility Name

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

12. IPD Sharing Statement

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Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer

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