Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer

NCT ID: NCT05877573

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-08-01

Brief Summary

This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

Conditions

Locally Advanced; High-Risk; Rectal Cancer; MSS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

short-course radiotherapy plus chemotherapy and immunotherapy

A total of 53 patients receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 2 cycles of CAPOX chemotherapy.

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

Toripalimab 240mg,d1,q3w

short-term radiotherapy

Intervention Type: RADIATION

25Gy/5Fx

Oxaliplatin

Intervention Type: DRUG

135mg/m2 d1 q3w

Capecitabine

Intervention Type: DRUG

1200mg/m2 d1-14 q3w

Interventions

Toripalimab

Toripalimab 240mg,d1,q3w

Intervention Type: DRUG

short-term radiotherapy

25Gy/5Fx

Intervention Type: RADIATION

Oxaliplatin

135mg/m2 d1 q3w

Intervention Type: DRUG

Capecitabine

1200mg/m2 d1-14 q3w

Intervention Type: DRUG

Other Intervention Names

shor-course radiotherapy

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years old, female and male;
• Pathological confirmed MSS or pMMR rectal adenocarcinoma;
• Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;
• No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;
• Adequate organ function defined at baseline as:

ANC ≥1.5××109/L，PLt ≥100×109 /L，Hb ≥90 g/L，15×109 /L≥WBC≥4×109 /L; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr

• 60ml/min (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);

• Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;

Exclusion Criteria

• Pathological confirmed rectal squamous cell carcinoma;
• History of other uncured malignancies within 5 years;
• Allergic to any component of chemotherapy or immunotherapy;
• History of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis.
• With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dehua Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Ding, MD

Role: CONTACT

dingyi197980@126.com

86-20-13729852980

Yaowei Zhang, MD

Role: CONTACT

weiyaozhang2@163.com

86-20-17819575181

Facility Contacts

Yaowei Zhang, MD

Role: primary

weiyaozhang2@163.com

86-20-17819575181

Other Identifiers

NFEC-2023-062

Identifier Type: -

Identifier Source: org_study_id