Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer

NCT06493240 | Completed Phase 2

• 2 other identifiers: 2023PHB222Z220014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.

Conditions

Locally Advanced Rectal Cancer

Keywords

Locally Advanced Rectal Cancer; PD-1 inhibition; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• pCR rate

  pathological complete response rate

  within 1 week after surgery

Secondary Outcomes (4)

• sphincter preserving rate

  instantly after surgery

• immune-related adverse event rate

  from commencing of PD-1 inhibition to the 30th day after surgery

• treatment-related adverse event rate

  from commencing of treatment to the 30th day after surgery

• incidence rate of surgical complications

  within 30 days after surgery

Study Arms (1)

nCRT+PD-1

EXPERIMENTAL

Long-course chemoradiation followed by PD-1 inhibition (Sintilimab 200mg, 3 times, 2-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 6 weeks after completion of radiation.

Radiation: radiation; Drug: PD-1 Monoclonal Antibody; Procedure: TME surgery

Interventions

radiation RADIATION

45 Gy radiation dose in 25 fractions to the pelvis

nCRT+PD-1

PD-1 Monoclonal Antibody DRUG

200mg Sintilimab after radiation (3 times, 2-week interval)

Also known as: Sintilimab

nCRT+PD-1

TME surgery PROCEDURE

TME surgery for 6\~8 weeks after radiation

Also known as: radical proctectomy

nCRT+PD-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18\~75
• ECOG score 0\~2
• biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
• no distant metastasis, staged II/III (T4b excluded) by MRI
• maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MR
• willing and able to comply with study protocol
• consent to the use of blood and tissue specimens for study
• no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.)
• no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.)
• no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.)
• no jaundice or gastrointestinal obstruction
• no acute/ongoing infection
• no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN
• no social or mental disorder

You may not qualify if:

• multiple cancers, or with concomitant malignant tumors besides rectal cancer
• having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
• history of recent major surgery
• with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
• with uncontrolled, severe, concomitant diseases of any sort
• allergic to any of the ingredients under study
• estimated survival ≤ 5 years due to any reason
• preparing for or having previously received organ or bone marrow transplant
• for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient or oral medication compliance
• with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.)
• pregnant or lactating women, or women intending on conception during treatment period

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

Radiation; spartalizumab; sintilimab

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Zhanlong Zhanlong, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Masking is not practically possible
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gastroenterological Surgery

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 9, 2024
• Study Start: January 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)