Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer

NCT06760520 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-KY-1578-002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-arm, prospective, phase II clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(TME) surgery in patients with advanced rectal cancer.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Complete response rate (CR, pCR plus cCR )

  pathological complete response rate plus clinical complete response rate

  pCR rate : within 1 week after surgery；cCR：12-13 weeks after radiotherapy ends

Secondary Outcomes (7)

• 3-years DFS rate

  From date of treatment until the date of first documented disease relapse or date of death from any cause, whichever came first about 3years.

• 5-years OS rate

  From date of treatment until date of death from any cause,about 5 years

• ORR

  up to 2 years

• Incidence and severity of adverse events (AEs)

  up to 2 years

• Tumor downstaging rate

  up to 2 years

Study Arms (1)

ivonescimab+chemotherapy

EXPERIMENTAL

Local advanced rectal cancer with short-course radiotherapy followed by sequential chemotherapy and ivonescimab

Drug: Ivonescimab (SMT112 or AK112) Injection

Interventions

Ivonescimab (SMT112 or AK112) Injection DRUG

Eligible subjects will receive short-course radiotherapy (SCRT), 25Gy/5f/1 week. 1-2 weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 850-1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).

ivonescimab+chemotherapy

Eligibility Criteria

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

You may qualify if:

• ECOG score of 0-1;
• histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis
• Tumor distance from anal verge ≦10cm
• at least one high-risk criterion defined by pelvic MRI: cT stage \>T2 (tumor invades intrinsic muscularis propria by more than 5 mm); Extramural vascular invasion; cN2; Involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); Lateral lymph node short diameter ≥5mm
• enough organ function

You may not qualify if:

• with known MSI-H or dMMR
• Multiple primary adenocarcinomas
• History of pelvic radiotherapy
• Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yugui Lian, M.D

CONTACT

+86 0371-66279076; fcclianyg@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 7, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2031
• Last Updated: January 8, 2025

Record last verified: 2024-12