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A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer

ConditionsRectal CancerTotal Neoadjuvant TherapyRadiotherapyImmunotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTao Zhang

About this trial

This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients or their family members agree to participate in the study and sign the informed consent form;

Age 18-75 years, male or female;

Histologically confirmed Locally Advanced rectal adenocarcinoma;

Immunohistochemistry and/or genetic testing confirmed pMMR/MSS;

Disqualifiers

Patients with MSI-H/dMMR LARC；

Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;

Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).

Trial design

Design model

Parallel

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.

  • Long-course radiotherapy

    Radiation

    Long-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine.

  • Capecitabine

    Drug

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

  • Oxaliplatin

    Drug

    130mg/m2, ivgtt, d1,q3w

  • HLX10

    Drug

    300mg, ivgtt, q3w

  • TME surgery

    Procedure/Surgery

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

  • HLX10 placebo

    Drug

    300mg, ivgtt, q3w

Treatment groups

444 Participants
are divided into 3 treatment groups
Group A: Group A: SCRT + iTNTExperimental treatment 5 interventions
Group B: Group B: LCRT + iTNTExperimental treatment 5 interventions
Group C: Group C: LCRT + TNTActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

3-year event-Free Survival

The time from the start of treatment to the occurrence of any of the following events, which ever occurs first: tumor disease progression on imaging as assessed by RECIST 1.1; tumor recurrence, including local recurrence or distant recurrence, as assessed on imaging or tissue biopsy transfer; death from any cause

Time frame
an expected average of 3 years

Secondary outcomes

1

complete response (CR) rate

Defined as pathological complete response (pCR) + Clinical complete response (cCR)

Time frame
an expected average of 12 months
2

Overall Survival

The time from the date of randomization to the death caused by any cause

Time frame
an expected average of 5 years
3

Adverse events (AEs) were graded according to the NCI CTCAE version 5·0

Adverse events and surgical safety

Time frame
an expected average of 1.5 years

Other outcomes

Sponsors and contacts

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

Tao Zhang

Lead sponsor

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

Sponsor institution

Source ClinicalTrials.gov
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