ClinicalTrials.Veeva

Menu

TIME in Immunotherapy Combined With nCRT for Rectal Cancer (TIMENT-R)

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Not yet enrolling
Phase 2

Conditions

Locally Advanced Rectal Cancer

Treatments

Drug: Capecitabine
Radiation: Long-course radiation therapy
Drug: PD-1 inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT05507112
PUMCH_TIMENT-R

Details and patient eligibility

About

This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

Full description

Objectives:

  1. To clarify the efficacy and safety of combined therapy for locally advanced rectal cancer (LARC) patients and verify the efficacy and safety of neoadjuvant immunotherapy for dMMR/MSI-H LARC patients.
  2. To clarify the effect of nCRT on TIME for rectal cancer, and the further effect of adding Immunotherapy.
  3. To verify the feasibility of predicting the efficacy of combined therapy by the infiltration level of CD8+ PD1+ TILs in tumor tissue before treatment in pMMR/MSS LARC patients and explore the comprehensive prediction index of the efficacy of combined therapy for LARC patients.
  4. To clarify the potential mechanism of immune response or immune escape to neoadjuvant immunotherapy for LARC patients.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age ≥ 18 years and ≤75 years on the day of signing informed consent.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  3. Histologically proven rectal adenocarcinoma.
  4. <12 cm from anal verge.
  5. Clinical stage of T3/T4 or N positive and M0
  6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment
  7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease, dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC), autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection.
  8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery.
  9. Willing and able to provide written informed consent.

Exclusion criteria

  1. Allergic to any component of chemotherapy or immunotherapy;
  2. Patients with multiple primary colorectal cancer;
  3. Other malignant tumors within 5 years, except for adequately treated cervical carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled localized prostate cancer or surgically excised ductal carcinoma in situ of breast;
  4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection;
  5. Prior or planed organ/bone marrow transplant
  6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study;
  7. Pregnant or lactating women
  8. Patients with a history of severe mental illness or being unable to comply with the research protocols.
  9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery.
  10. Patients who have any other conditions that investigator judges unsuitable to participate.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Neoadjuvant chemoradiotherapy plus PD-1 inhibitor
Experimental group
Description:
Capecitabine 1650mg/m2 is given 5 days a week in parallel with radiotherapy 45 to 50 Gy during 5 consecutive weeks. Tislelizumab is given on day 1 of week 2, 5 and 8 at 200 mg i.v. 8-12 weeks after completion of radiation therapy, patients undergo total mesorectal excision (TME).
Treatment:
Drug: PD-1 inhibitor
Radiation: Long-course radiation therapy
Drug: Capecitabine
Neoadjuvant chemoradiotherapy
Active Comparator group
Description:
Capecitabine 1650mg/m2 is given 5 days a week in parallel with radiotherapy 45 to 50 Gy during 5 consecutive weeks. 8-12 weeks after completion of radiation therapy, patients undergo total mesorectal excision (TME).
Treatment:
Radiation: Long-course radiation therapy
Drug: Capecitabine

Trial contacts and locations

0

Loading...

Central trial contact

Jiaolin Zhou, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems