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

• Sponsor: Wuhan Union Hospital, China (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04231552
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 46.7
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer; Radiotherapy; Immunotherapy	Drug: Camrelizumab	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preoperative Short Course Radiotherapy With Consolidation Chemotherapies and Camrelizumab Followed by Delayed Surgery in Locally Advanced Rectal Cancer
• Actual Study Start Date: Nov 10, 2019
• Actual Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pathological complete response [1 year]

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

Secondary Outcome Measures

1. margin-free (R0) resection rate [1 years]

   margin-free (R0) resection rate

2. 3-year event-free survival rate [3 years]

   3-year event-free survival rate

3. safety, and quality of life [1 year]

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

4. 3-year overall survival rate [3 year]

   3-year overall survival rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China

Sponsors and Collaborators

• Wuhan Union Hospital, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ciseł B, Pietrzak L, Michalski W, Wyrwicz L, Rutkowski A, Kosakowska E, Cencelewicz A, Spałek M, Polkowski W, Jankiewicz M, Styliński R, Bębenek M, Kapturkiewicz B, Maciejczyk A, Sadowski J, Zygulska J, Zegarski W, Jankowski M, Las-Jankowska M, Toczko Z, Żelazowska-Omiotek U, Kępka L, Socha J, Wasilewska-Tesluk E, Markiewicz W, Kładny J, Majewski A, Kapuściński W, Suwiński R, Bujko K; Polish Colorectal Study Group. Long-course preoperative chemoradiation versus 5 × 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.

• Responsible Party: Tao Zhang, Chief of gastrointestinal oncology, Wuhan Union Hospital, China
• ClinicalTrials.gov Identifier: NCT04231552
• Other Study ID Numbers: WUGO-001
• First Posted: Jan 18, 2020
• Last Update Posted: Nov 30, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Nov 30, 2020