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Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

ConditionsLocally Advanced Rectal CancerNeoadjuvant Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance；

Age ≥18 years and ≤75 years, without gender restriction.

Histopathologically confirmed locally advanced rectal adenocarcinoma.

Participants who are not suitable for standard therapy due to intolerable toxicity, lack of standard therapy, or refusal of standard therapy.

Disqualifiers

Exclusion of patients not diagnosed with locally advanced rectal adenocarcinoma.

Participants who have previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or any other treatments targeting tumor immunological mechanisms, such as immune cell therapy.

Pregnant or breastfeeding women, or women planning to become pregnant during the period from before the administration of the study drug, during treatment, or up to 6 months after the last dose.

Known history of active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, or new onset of brain or leptomeningeal metastases.

Trial design

Design model

Single group

Treatments tested in this trial

  • short-course radiotherapy

    Radiation

    Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles.

  • Ivonescimab

    Drug

    AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W)

  • capecitabine

    Drug

    1000mg/m2, bid, po, d1-14,q3w

  • oxaliplatin

    Drug

    130mg/m2, ivgtt, d1,q3w

  • TME surgery

    Procedure/Surgery

    The surgery was performed 1 week after the end of neoadjuvant therapy.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: SCRT+AK112+chemotherapyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Pathologic complete response rate (pCR)

Pathological complete response will be made based on assessment of the surgical specimen at the primary treatment site，the absence of any viable tumor cells in the resected primary tumor specimen and all regional lymph node samples.

Time frame
though 19 weeks neoadjuvant treatment，after surgery completed

Secondary outcomes

1

3-years Event-Free Survival rate

from the start of randomized treatment assignment until the occurrence of a predefined event

Time frame
3 years
2

OS

To compute the length between end of treatment and death

Time frame
From date of randomization until date of death from any cause，up to 3 years
3

R0 resection rate

The rate of negative margin microscopically

Time frame
From date of surgry，up to 1month
4

AE

To assess the result from inspection paper during the trail，adverse events (AEs) were graded according to the NCl CTCAE version 5.0

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

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

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

Lead sponsor

Source ClinicalTrials.gov
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