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

NCT05877573 | Recruiting

• 1 other identifier: NFEC-2023-062
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• pCR rate

  Pathologic complete response rate

  The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months

Secondary Outcomes (5)

• 3-year ORR

  Assessed up to 3 years

• 3-year DCR

  Assessed up to 3 years

• 3-year OS

  Assessed up to 3 years

• AE

  Assessed up to 3 years

• SAE

  Assessed up to 3 years

Study Arms (1)

short-course radiotherapy plus chemotherapy and immunotherapy

EXPERIMENTAL

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.

Drug: Toripalimab; Radiation: short-term radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Toripalimab DRUG

Toripalimab 240mg,d1,q3w

short-course radiotherapy plus chemotherapy and immunotherapy

short-term radiotherapy RADIATION

25Gy/5Fx

Also known as: shor-course radiotherapy

short-course radiotherapy plus chemotherapy and immunotherapy

Oxaliplatin DRUG

135mg/m2 d1 q3w

short-course radiotherapy plus chemotherapy and immunotherapy

Capecitabine DRUG

1200mg/m2 d1-14 q3w

short-course radiotherapy plus chemotherapy and immunotherapy

Eligibility Criteria

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

You may qualify if:

• 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
• ml/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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

Study Sites (1)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

toripalimab; Oxaliplatin; Capecitabine

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)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Dehua Wu, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ding, MD

CONTACT

86-20-13729852980; dingyi197980@126.com

Yaowei Zhang, MD

CONTACT

86-20-17819575181; weiyaozhang2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)