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

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

Sponsors

Lead sponsor: Wuhan Union Hospital, China

Source Wuhan Union Hospital, China
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 (cT3-4a with 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.

Overall Status Recruiting
Start Date November 10, 2019
Completion Date June 10, 2021
Primary Completion Date November 10, 2020
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Pathological complete response 1 year
Secondary Outcome
Measure Time Frame
Disease-free survival (DFS) 5 years
Overall survival (OS) 5 years
Incidence of adverse events (AEs) 1 year
Enrollment 50
Condition
Intervention

Intervention type: Drug

Intervention name: Camrelizumab

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)

Arm group label: Chemotherapy and PD1 inhibitor

Other name: Radiotherapy with CAPOX+ Camrelizumab following surgical therapy

Eligibility

Criteria:

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/T4a 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Tao Zhang, MD Principal Investigator Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Overall Contact

Last name: Zhenyu Lin, MD

Phone: 027-85871982

Email: [email protected]

Location
facility status contact contact_backup Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Tao Zhang, MD, PHD 862785871982 [email protected]
Location Countries

China

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Wuhan Union Hospital, China

Investigator full name: Tao Zhang

Investigator title: Chief of gastrointestinal oncology

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Chemotherapy and PD1 inhibitor

Arm group type: Experimental

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).

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov