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Preoperative Short Course Radiotherapy With Chemotherapy and Camerelizumab in Locally Advanced Rectal Cancer

Primary Purpose

Rectal Cancer, Radiotherapy, Immunotherapy

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Camrelizumab

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
Primary rectal cancer histopathologically confirmed to be adenocarcinoma
Clinical stage of T3/T4 or N positive and M0,before CRT
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

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

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy and PD1 inhibitor

Arm Description

CAPOX (2 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine:Dose of 2000mg/m2,14days, q3w Camrelizumab (2 cycles): 200mg on day 1 of each cycle, q3w Surgical therapy: the resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR).

Outcomes

Primary Outcome Measures

Pathological complete response

Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging

Secondary Outcome Measures

margin-free (R0) resection rate

3-year event-free survival rate

safety, and quality of life

Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.

3-year overall survival rate

Full Information

NCT ID

NCT04231552

First Posted

January 4, 2020

Last Updated

November 25, 2020

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT04231552

Brief Title

Preoperative Short Course Radiotherapy With Chemotherapy and Camerelizumab in Locally Advanced Rectal Cancer

Official Title

Preoperative Short Course Radiotherapy With Consolidation Chemotherapies and Camrelizumab Followed by Delayed Surgery in Locally Advanced Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 10, 2019 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

September 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

Data Monitoring Committee

5. Study Description

Brief Summary

This is a open-label, single-arm study to investigate the safety and efficacy of consolidative chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

Detailed Description

Patients with locally advanced rectal cancer (cT3-4 or N+) are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with consolidation chemotherapy consisting two cycles of CAPOX chemotherapy and camrelizumab, an anti-PD-1 antibody drug for two cycles. Subsequent surgical therapy is performed to evaluate the safety and efficacy.

6. Conditions and Keywords

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

Rectal Cancer, Radiotherapy, Immunotherapy

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

Chemotherapy and PD1 inhibitor

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Other Intervention Name(s)

Radiotherapy with CAPOX+ Camrelizumab following surgical therapy

Intervention Description

Radiotherapy with CAPOX+ Camrelizumab following surgical therapy Radiation: 25 Gy/5 fractions CAPOX (2 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine:Dose of 2000mg/m2,14days, q3w Camrelizumab (2 cycles): 200mg on day 1 of each cycle, q3w Surgical therapy: the resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)

Primary Outcome Measure Information:

Title

Pathological complete response

Description

Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging

Time Frame

1 year

Secondary Outcome Measure Information:

Title

margin-free (R0) resection rate

Description

margin-free (R0) resection rate

Time Frame

1 years

Title

3-year event-free survival rate

Description

3-year event-free survival rate

Time Frame

3 years

Title

safety, and quality of life

Description

Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.

Time Frame

1 year

Title

3-year overall survival rate

Description

3-year overall survival rate

Time Frame

3 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 Primary rectal cancer histopathologically confirmed to be adenocarcinoma Clinical stage of T3/T4 or N positive and M0,before CRT 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tao Zhang, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31192355

Citation

Cisel B, Pietrzak L, Michalski W, Wyrwicz L, Rutkowski A, Kosakowska E, Cencelewicz A, Spalek M, Polkowski W, Jankiewicz M, Stylinski R, Bebenek M, Kapturkiewicz B, Maciejczyk A, Sadowski J, Zygulska J, Zegarski W, Jankowski M, Las-Jankowska M, Toczko Z, Zelazowska-Omiotek U, Kepka L, Socha J, Wasilewska-Tesluk E, Markiewicz W, Kladny J, Majewski A, Kapuscinski W, Suwinski R, Bujko K; Polish Colorectal Study Group. Long-course preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study. Ann Oncol. 2019 Aug 1;30(8):1298-1303. doi: 10.1093/annonc/mdz186.

Results Reference

background

PubMed Identifier

34725214

Citation

Lin Z, Cai M, Zhang P, Li G, Liu T, Li X, Cai K, Nie X, Wang J, Liu J, Liu H, Zhang W, Gao J, Wu C, Wang L, Fan J, Zhang L, Wang Z, Hou Z, Ma C, Yang K, Wu G, Tao K, Zhang T. Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer. J Immunother Cancer. 2021 Nov;9(11):e003554. doi: 10.1136/jitc-2021-003554. Erratum In: J Immunother Cancer. 2022 Feb;10(2):

Results Reference

derived

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Preoperative Short Course Radiotherapy With Chemotherapy and Camerelizumab in Locally Advanced Rectal Cancer

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