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The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer

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Fudan University

Status and phase

Unknown
Phase 2

Conditions

Locally Advanced Rectal Cancer

Treatments

Drug: Capecitabine
Drug: Irinotecan
Drug: PD-1 antibody
Radiation: Neoadjuvant Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04411537
FDRT-2019-97-1731

Details and patient eligibility

About

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. pathological confirmed adenocarcinoma
  2. clinical stage T3-4 and/or N+
  3. the distance from anal verge less than 12 cm
  4. without distance metastases
  5. age 18-70 years old, female and male
  6. KPS >=70
  7. UGT1A1*28 6/6 or 6/7
  8. the MSI status is MSS or p-MMR
  9. without previous anti-cancer therapy or immunotherapy
  10. with good compliance
  11. signed the inform consent

Exclusion criteria

  1. pregnancy or breast-feeding women
  2. history of other malignancies within 5 years
  3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
  4. immunodeficiency disease or long-term using of immunosuppressive agents
  5. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
  6. DPD deficiency
  7. UGT1A1*28 7/7
  8. the MSI status is MSI-H or d-MMR
  9. allergic to any component of the therapy

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Treatment Arm
Experimental group
Description:
A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX.
Treatment:
Radiation: Neoadjuvant Radiotherapy
Drug: PD-1 antibody
Drug: Irinotecan
Drug: Capecitabine

Trial contacts and locations

1

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Central trial contact

zhen zhang, M.D, PH.D

Data sourced from clinicaltrials.gov

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