Clinical Trials /

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

NCT04411537

Description:

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.

Related Conditions:
  • Rectal Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer
  • Official Title: A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Stable Locally Advanced Rectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: FDRT-2019-97-1731
  • NCT ID: NCT04411537

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DrugSynonymsArms
PD-1 antibodyTreatment Arm
CapecitabineXelodaTreatment Arm
IrinotecanTreatment Arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment ArmExperimentalA 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.
  • PD-1 antibody
  • Capecitabine
  • Irinotecan

Eligibility Criteria

        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
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic Complete Response Rate
Time Frame:The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy
Safety Issue:
Description:Pathologic Complete Response Rate

Secondary Outcome Measures

Measure:Disease free survival
Time Frame:From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Safety Issue:
Description:3 year disease free survival rate
Measure:Local recurrence free survival
Time Frame:From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
Safety Issue:
Description:3 year local recurrence free survival rate
Measure:Overall survival
Time Frame:From date of randomization until the date of death from any cause, assessed up to 36 months.
Safety Issue:
Description:3 year overall survival rate
Measure:Adverse effects
Time Frame:From date of randomization until the date of death from any cause, assessed up to 5 years
Safety Issue:
Description:Chemoradiation-related or immunotherapy-related adverse events
Measure:Surgical complications
Time Frame:The surgery was scheduled 7-8 weeks after the end of chemoradiotherapy. And the surgical complications were assessed up to 5 years from the surgery.
Safety Issue:
Description:Surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Measure:Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life.
Time Frame:From date of randomization until the date of death from any cause, assessed up to 10 years
Safety Issue:
Description:Quality of life will be evaluated
Measure:Karnofsky Performance Status, range 0-100. The higher scores mean a better quality of life.
Time Frame:From date of randomization until the date of death from any cause, assessed up to 10 years
Safety Issue:
Description:Quality of life will be evaluated
Measure:Quality of Life Scale, range 0-60. It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Time Frame:From date of randomization until the date of death from any cause, assessed up to 10 years
Safety Issue:
Description:Quality of life will be evaluated

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Fudan University

Last Updated

June 1, 2020