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MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

ConditionLocally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years old, male or female

Pathologically confirmed rectal adenocarcinoma

The distance from anal verge ≤ 10 cm

Clinical stage T3-4 and/or N+

Disqualifiers

Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ

Pregnancy or breast-feeding women

Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications

Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 antibody

    Drug

    PD-1 antibody (Toripalimab): 240mg d1 q3w

  • Oxaliplatin

    Drug

    Oxaliplatin: 130mg/m2 d1 q3w

  • Capecitabine

    Drug

    Capecitabine: 1000mg/m2 bid d1-14 q3w

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 3 interventions
Group B: Group BExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate

Rate of pathologic complete response (pCR) after surgery

Time frame
1 month after the surgery

Secondary outcomes

1

Grade 3-4 adverse effects rate

Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

Time frame
From the date of randomization until 3 months after the completion neoadjuvant therapy
2

Anal function

Anal function will be evaluated using LARS score

Time frame
From the date of randomization until 36 months after the surgery
3

Surgical complication

Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.

Time frame
The surgical complications were assessed within 3 months after the surgery
4

3-year local recurrence free survival (LRFS) rate

Rate of 3-year local recurrence free survival

Time frame
From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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