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SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer

ConditionsRectal CancerLocally Advanced
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent

18 years < age ≤ 75 years

ECOG score is 0-1

Patients with pathologically confirmed rectal adenocarcinoma, assessed by MRI as mid-low rectal cancer (the lower border of the tumor is less than 10cm from the anal verge), clinical stage II-III (cT1-2N1-2M0 or T3-4N0-2M0) according to the 8th Edition of AJCC Cancer Staging Manual

Disqualifiers

Recurrent rectal cancer

Previous treatment with pelvic radiotherapy, rectal cancer surgery, chemotherapy, targeted therapy, immune checkpoint inhibitors (including but not limited to PD-1, PD-L1, CTLA-4)

Proven inability to receive radiotherapy or allergy to the components of Penpulimab, capecitabine, oxaliplatin or their excipients

Intestinal obstruction due to tumor (except in patients who have received a stoma)

Trial design

Design model

Single group

Treatments tested in this trial

  • Short-course radiotherapy

    Radiation

    5×5Gy in Week 1

  • Penpulimab

    Drug

    Apply once in the first week, then every 3 weeks from the third week for four cycles

  • CAPEOX

    Drug

    Apply every 3 weeks from week 3 for 4 cycles

  • TME surgery

    Procedure/Surgery

    Patient will receive radical rectal cancer surgery

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: SCRT sequential Penpulimab in combination with CAPEOXExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological complete remission rate (pCR)

The proportion of complete remissions detected by postoperative pathological examination (%)

Time frame
One month after surgery

Secondary outcomes

1

Clinical complete remission rate (cCR)

The proportion of complete remissions detected by imaging, endoscopy and digital rectal examination (%)

Time frame
Three weeks after neoadjuvant therapy
2

Objective response rate (ORR)

Sum of proportion in complete and partial remission (%)

Time frame
One month after surgery
3

3-year disease free survival rate (3y-DFS)

3-year disease free survival rate estimated based on Kaplan-Meier method

Time frame
36 months after surgery
4

R0 resection rate

Histologically complete resection rate (%)

Time frame
One month after surgery

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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