Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06770270

Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-09-04

68

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Colorectal cancer is a common gastrointestinal tumor, with rising incidence in China. Rectal cancer accounts for nearly half of new cases, and many patients are diagnosed at a locally advanced stage. Neoadjuvant chemoradiotherapy (nCRT) is the standard treatment, but only 20-30% achieve a complete response, with many experiencing recurrence or metastasis. Immunotherapy, particularly PD-1/PD-L1 inhibitors, has shown promise in improving outcomes, especially in dMMR/MSI-H patients. However, most rectal cancer patients have MSS, where combining immunotherapy with nCRT has shown moderate success in clinical trials. This project aims to explore the safety and efficacy of PD-1 inhibitor (pucotenlimab) combined with nCRT for locally advanced rectal cancer, potentially offering new treatment options.

CONDITIONS

Official Title

Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient voluntarily agrees to participate and can comply with follow-up
  • Age between 18 and 75 years, inclusive, any gender
  • Histologically confirmed locally advanced rectal adenocarcinoma (cT3 or higher, or cN+ confirmed by MRI)
  • Tumor lower edge is 10 cm or less from the anal verge confirmed by MRI
  • No prior anti-tumor treatment for rectal cancer except traditional Chinese medicine
  • ECOG performance status score of 0 or 1
  • Adequate major organ function within 2 weeks before study without blood component or growth factor correction
  • Women of childbearing potential agree to use effective contraception or abstain from heterosexual intercourse from consent signing until 6 months after last dose, with negative serum HCG test
  • Male patients with partners of childbearing potential agree to use contraception or abstain from intercourse from consent signing until 6 months after last dose, and not donate sperm during this period
Not Eligible

You will not qualify if you...

  • Previous treatment for locally recurrent rectal cancer
  • Initially unresectable rectal cancer or unable to tolerate surgery
  • Evidence of distant metastasis or positive lateral lymph nodes
  • Multiple colorectal cancer lesions
  • Evidence or high risk of bowel obstruction, perforation, or bleeding
  • Unsuitable for long-course radiotherapy as judged by investigator
  • Severe cardiovascular or cerebrovascular diseases within 6 months prior to enrollment
  • Active or untreated pulmonary tuberculosis
  • Major surgery within 3 months before starting treatment or non-healing wounds
  • Difficulty swallowing or other factors affecting oral medication use
  • Contraindications to MRI
  • Active or history of autoimmune diseases except controlled thyroid disorders or minor skin diseases
  • History of immunodeficiency or organ transplantation
  • Severe infections within 4 weeks before treatment
  • Interstitial lung disease or lung conditions affecting lung toxicity assessment
  • Active hepatitis B or C infection
  • Another malignancy diagnosed within 5 years except certain treated skin or in situ cancers
  • Allergy or contraindication to pucotenlimab, oxaliplatin, capecitabine, or their components
  • Use of immunosuppressants or corticosteroids above specified doses within 14 days before treatment
  • Participation in another clinical study within 4 weeks before treatment
  • Untreatable electrolyte abnormalities within 2 weeks before treatment
  • Receipt or planned receipt of live vaccines within specified timeframes
  • Pregnant or breastfeeding women
  • Other factors affecting study results or participant safety as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital Of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

H

Haiyan Chen, Ph.D. and M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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