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

ConditionLocally Advanced Rectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ivonescimab+chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete response rate (CR, pCR plus cCR )

pathological complete response rate plus clinical complete response rate

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

Secondary outcomes

1

3-years DFS rate

Time frame
From date of treatment until the date of first documented disease relapse or date of death from any cause, whichever came first about 3years.
2

5-years OS rate

Time frame
From date of treatment until date of death from any cause,about 5 years
3

ORR

objective response rate

Time frame
up to 2 years
4

Incidence and severity of adverse events (AEs)

Time frame
up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: