Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07198165

SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC

This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Rectal Cancer Chemoradiotherapy Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Immunotherapy Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Adenocarcinoma Rectal Cancer Patients Rectal Cancer, Radiotherapy Rectal Diseases Rectal Neoplasms Targeted Therapy Total Neoadjuvant Therapy Total Neoadjuvant Treatment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Bo Feng

CONTACT

[email protected]

+86 21 64370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.
  • Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.
  • Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET/CT.
  • Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.
  • Age 18 to 75 years.
  • ECOG Performance Status of 0 to 1, without severe comorbid medical conditions.
  • Adequate organ function:

Hematopoietic: Hemoglobin ≥90 g/L, Platelets ≥80 × 10^9/L, Absolute Neutrophil Count ≥1.5 × 10^9/L.

Hepatic: ALT and AST < 2.5 × ULN. Renal: Serum Creatinine < 1.5 × ULN.

  • Provision of signed and dated written informed consent.

Exclusion criteria

  • Patients found to have BRAF mutations or MSI-H status.
  • Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.
  • History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.
  • Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.
  • Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.
  • Patients with active infections.
  • Poor overall health status, with an ECOG performance status ≥2.
  • Patients who have undergone organ transplantation requiring immunosuppressive therapy, or those requiring long-term corticosteroid treatment for autoimmune diseases.
  • Patients with comorbid conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study.
  • Known hypersensitivity to any of the study drugs.

Treatment and study plan

PD-1 inhibitor based immunotherapy

Drug

Short-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) + PD-1 inhibitor (Toripalimab 240mg IV infusion, D1, Q3w).

Primary outcomes

  1. Complete Response rate

    Time frame: 2 weeks after the surgery

    Measurement Methods:

    Chi-square test, Fisher's exact test, multivariate regression analysis (Cox regression model).

    Description:

    For pCR and cCR, chi-square test or Fisher's exact test was used to compare differences between the two groups. Multivariate regression analysis (Cox regression model) was employed to assess the relationship between the intervention and the CR rate.

Secondary outcomes

  1. Disease-Free Survival (DFS)

    Time frame: from enrollment to the end of follow-up at 48 months

    Measurement Method:

    Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.

    Methods for Handling Missing Values:

    • For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
    • For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.

  2. Distant Metastasis Rate

    Time frame: from enrollment to the end of follow-up at 48 months

    Measurement Method:

    Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.

    Methods for Handling Missing Values:

    • For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
    • For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.

  3. Local Recurrence Rate

    Time frame: from enrollment to the end of follow-up at 48 months

    Measurement Method:

    Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.

    Methods for Handling Missing Values:

    • For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
    • For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.

  4. Overall Survival (OS)

    Time frame: from enrollment to the end of follow-up at 48 months

    Measurement Method:

    Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.

    Methods for Handling Missing Values:

    • For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
    • For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.

  5. Pathological Stage

    Time frame: 2 weeks after the surgery

    ypT and ypN staging

    Measurement Method:

    Chi-square test or Fisher's exact test

  6. Tumor Regression Grade(TRG)

    Time frame: 2 weeks after the surgery

    Measurement Method:

    Chi-square test or Fisher's exact test

  7. Sphincter Preservation Rate

    Time frame: 2 weeks after the surgery

    Measurement Method:

    Logistic regression analysis

    Methods for Handling Missing Values:

    • For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
    • For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Feng

CONTACT

[email protected]

+86 21 64370045 ext. +86 1351210399

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.