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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Cancer; Radiotherapy; Immunotherapy
• Intervention / Treatment: Drug: Camrelizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who personally provided written consent for participation in the study
2. 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
3. Primary rectal cancer histopathologically confirmed to be adenocarcinoma
4. Clinical stage of T3/T4 or N positive and M0,before CRT
5. Patients with the ECOG performance status of 0 or 1 at the time of enrollment
6. 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
7. 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:

1. Patients with recurrent rectal cancer or a history of pelvic radiation
2. Patients with a history of inflammatory bowel disease
3. Patients with a history of pneumonitis or interstitial lung disease
4. Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
5. Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
6. Patients with a history of thyroid dysfunction
7. Patients with a history or finding of cardiovascular risk
8. Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody
9. Patients who are pregnant or lactating or who may be pregnant
10. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Chemotherapy and PD1 inhibitor; 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).

Drug: Camrelizumab; 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); Other Names: Radiotherapy with CAPOX+ Camrelizumab following surgical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response	Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
margin-free (R0) resection rate	margin-free (R0) resection rate	1 years
3-year event-free survival rate	3-year event-free survival rate	3 years
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.	1 year
3-year overall survival rate	3-year overall survival rate	3 year

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Tao Zhang, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

General Publications

• 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.
• 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). pii: e003554. doi: 10.1136/jitc-2021-003554. Erratum in: J Immunother Cancer. 2022 Feb;10(2):.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: January 4, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: WUGO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No