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Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

ConditionsLocally Advanced Rectal CancerNeoadjuvant Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years, gender not limited

Pathologically confirmed rectal adenocarcinoma

≤10 cm from the anus

Baseline stage T3-4/N+

Disqualifiers

Pregnancy or breast-feeding women;

Known history of other malignancies within 5 years;

Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;

Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Long-course radiotherapy

    Radiation

    Long-course radiation: 50Gy/25Fx

  • Oxaliplatin

    Drug

    Oxaliplatin: 130mg/m2 d1 q3w

  • Capecitabine

    Drug

    Xeloda

  • Celecoxib

    Drug

    celecoxib 200 mg orally twice a day

  • Short-course radiotherapy

    Radiation

    Short-course radiotherapy: 25Gy/5Fx

  • Serplulimab

    Drug

    Serplulimab 300mg, d1, q3w

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Long-course Radiotherapy plus chemotherapy groupExperimental treatment 5 interventions
Group B: Short-course Radiotherapy plus immunochemotherapy groupExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Complete response (CR) rate

Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.

Time frame
1 month after the surgery or the decision of W&W

Secondary outcomes

1

Grade 3-4 adverse effects rate

Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

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

3 year anal preservation rate

3 year anal preservation rate

Time frame
From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 36 months.
3

3 year disease free survival rate

Rate of 3 year disease free survival

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
4

3 year local recurrence free survival rate

Rate of 3 year local recurrence free survival

Time frame
From 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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