Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer

NCT04558684 | Suspended Phase 1

• 1 other identifier: WUGO-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Radiotherapy; Immunotherapy; Organ Preservation

Outcome Measures

Primary Outcomes (1)

• Clinical complete response rate (cCR)

  Proportion of patients who achieve a clinical complete response following treatment

  8 (+/-4 ) weeks

Secondary Outcomes (4)

• Local regrowth rate

  2 year

• Disease free survival (DFS)

  5 year

• Overall survival (OS)

  5 year

• Incidence of adverse events (AEs)

  1 year

Study Arms (1)

radiotherapy, chemotherapy and PD1 inhibitor

EXPERIMENTAL

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.

Drug: Chemotherapy; Drug: Immunotherapy; Radiation: IMRT

Interventions

Chemotherapy DRUG

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

radiotherapy, chemotherapy and PD1 inhibitor

Immunotherapy DRUG

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

radiotherapy, chemotherapy and PD1 inhibitor

IMRT RADIATION

Radiotherapy (5 Gy x 5 fractions)

radiotherapy, chemotherapy and PD1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of gastrointestinal oncology

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: November 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

CN (1)