NCT04231552

Brief Summary

This is a open-label, single-arm study to investigate the safety and efficacy of consolidative chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

January 4, 2020

Last Update Submit

November 25, 2020

Conditions

Rectal CancerRadiotherapyImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response

    Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging

    1 year

Secondary Outcomes (4)

  • margin-free (R0) resection rate

    1 years

  • 3-year event-free survival rate

    3 years

  • safety, and quality of life

    1 year

  • 3-year overall survival rate

    3 year

Study Arms (1)

Chemotherapy and PD1 inhibitor

EXPERIMENTAL

CAPOX (2 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine:Dose of 2000mg/m2,14days, q3w Camrelizumab (2 cycles): 200mg on day 1 of each cycle, q3w Surgical therapy: the resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR).

Drug: Camrelizumab

Interventions

CamrelizumabDRUG

Radiotherapy with CAPOX+ Camrelizumab following surgical therapy Radiation: 25 Gy/5 fractions CAPOX (2 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine:Dose of 2000mg/m2,14days, q3w Camrelizumab (2 cycles): 200mg on day 1 of each cycle, q3w Surgical therapy: the resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)

Also known as: Radiotherapy with CAPOX+ Camrelizumab following surgical therapy
Chemotherapy and PD1 inhibitor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who personally provided written consent for participation in the study
  • Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT
  • Primary rectal cancer histopathologically confirmed to be adenocarcinoma
  • Clinical stage of T3/T4 or N positive and M0,before CRT
  • Patients with the ECOG performance status of 0 or 1 at the time of enrollment
  • Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy
  • Male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug

You may not qualify if:

  • Patients with recurrent rectal cancer or a history of pelvic radiation
  • Patients with a history of inflammatory bowel disease
  • Patients with a history of pneumonitis or interstitial lung disease
  • Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
  • Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
  • Patients with a history of thyroid dysfunction
  • Patients with a history or finding of cardiovascular risk
  • Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody
  • Patients who are pregnant or lactating or who may be pregnant
  • Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Related Publications (3)

  • Cisel B, Pietrzak L, Michalski W, Wyrwicz L, Rutkowski A, Kosakowska E, Cencelewicz A, Spalek M, Polkowski W, Jankiewicz M, Stylinski R, Bebenek M, Kapturkiewicz B, Maciejczyk A, Sadowski J, Zygulska J, Zegarski W, Jankowski M, Las-Jankowska M, Toczko Z, Zelazowska-Omiotek U, Kepka L, Socha J, Wasilewska-Tesluk E, Markiewicz W, Kladny J, Majewski A, Kapuscinski W, Suwinski R, Bujko K; Polish Colorectal Study Group. Long-course preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study. Ann Oncol. 2019 Aug 1;30(8):1298-1303. doi: 10.1093/annonc/mdz186.

    PMID: 31192355BACKGROUND

  • Lin Z, Zhang P, Cai M, Li G, Liu T, Cai K, Wang J, Liu J, Liu H, Zhang W, Gao J, Wu C, Wang L, Wang Z, Hou Z, Kou H, Tao K, Zhang T. Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer: 3-year survival from a phase 2 study. BMC Med. 2025 May 9;23(1):273. doi: 10.1186/s12916-025-04087-x.

    PMID: 40346524DERIVED

  • Lin Z, Cai M, Zhang P, Li G, Liu T, Li X, Cai K, Nie X, Wang J, Liu J, Liu H, Zhang W, Gao J, Wu C, Wang L, Fan J, Zhang L, Wang Z, Hou Z, Ma C, Yang K, Wu G, Tao K, Zhang T. Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer. J Immunother Cancer. 2021 Nov;9(11):e003554. doi: 10.1136/jitc-2021-003554.

    PMID: 34725214DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

camrelizumabRadiotherapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Tao Zhang, MD

    Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of gastrointestinal oncology

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 18, 2020

Study Start

November 10, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2023

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)