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Active, not recruitingNCT04833387Updated Jan 11, 2023

PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer

A Phase 2 interventional study of PD-1 antibody in Colorectal Carcinoma, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-11.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Jan 2021, registered Apr 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.

02

Conditions studied

  • Colorectal Carcinoma
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 30 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 was at a distance of 12 cm or less from the AV before CRT
  • Primary rectal cancer histopathologically confirmed to be adenocarcinoma
  • Clinical stage of T3,and T4 ,N any,M0,before CRT
  • Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT
  • Patients with the ECOG performance status of 0 or 1 at the time of enrollment
  • Patients without distant metastasis on the imaging test before CRT
  • Preoperative biopsy of tumor immunohistochemistry TPS>1% or CPS>1
  • Life expectancy of greater than 2 years
  • No signs of intestinal obstruction; or the obstruction has been relieved after the proximal colostomy operation
  • Hematology: WBC>4000/mm3; PLT>100000/mm3; Hb>10g/dL
  • Liver function: SGOT and SGPT are less than 1.5 times the normal value; bilirubin is less than 1.5mg/dL
  • Renal function: creatinine \<1.8mg/dL Others: non-pregnant or breast-feeding women; no other malignant diseases (except for non-melanoma or cervical carcinoma in situ) within 5 years or during the same period; no mental illness that causes the inability to obtain informed consent; no other serious diseases that can shorten the survival time disease.
  • Have not received rectal surgery in the past;
  • Have not received chemotherapy or radiotherapy in the past;
  • Have not received biological treatment in the past;
  • Past endocrine therapy: unlimited.

Exclusion criteria

Exclusion Criteria:

  • Rectal cancer with unstable microsatellite (MSI or dMMR);
  • Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1
  • Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high copy viral DNA);
  • Autoimmune diseases;
  • Other active clinical serious infections (>NCI-CTC version 3.0);
  • Patients in clinical phase I;
  • There is evidence that there is distant metastasis before surgery;
  • Cachexia, decompensation of organ function;
  • Have a history of pelvic or abdominal radiotherapy;
  • Multiple primary cancers;
  • Patients who need treatment for seizures (such as steroids or anti-epileptic treatment);
  • Have a known additional malignant tumors within 5 years. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer;
  • Chronic inflammatory bowel disease, intestinal obstruction;
  • Drug abuse and medical, psychological or social conditions may interfere with patients' participation in research or have an impact on the evaluation of research results;
  • Known or suspected to be allergic to the study drug or to any drug given in connection with this test;
  • Any unstable conditions or situations that may endanger patient safety and compliance
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    PD-1 antibody + capecitabine + radiation

    Drug: PD-1 antibody

Interventions

  • DrugPD-1 antibody

    Capecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)

06

What researchers measure

Primary outcomes

  1. Pathological complete response

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

    Time frame: 1 year

Secondary outcomes

  1. Relapse-free survival (RFS)

    Time frame: 3 years

  2. Overall survival (OS)

    Time frame: 3 years

  3. Clinical complete response (CCR)

    Time frame: 1 year

07

Study locations

1 site
  • 651 Dongfeng Road East
    Guangzhou, Guangdong 510060, China
08

References and documents

Publications

  • Hou Z, Liao L, Xiao W, Sui Q, Han K, Xiao B, Li Y, Mei W, Yu J, Hong Z, Chen Q, Song R, Li D, Zhang X, Wang Q, Pan Z, Jiang W, Ding P. Neoadjuvant chemoradiotherapy plus sintilimab in pMMR/MSS rectal cancer patients with PD-L1 TPS >/= 1% or CPS >/= 1: an open-label, prospective, phase II study. NPJ Precis Oncol. 2025 Jul 12;9(1):237. doi: 10.1038/s41698-025-01018-0. PubMed 40652024 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Dec 2024, 47 months after the start.

Of 476 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 72. This study's planned 47 months is close to that.

Counting every sponsor, half of 584 studies reached it within 47 months; a quarter within 30 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2021
First posted
Apr 6, 2021
StartActual
Jan 1, 2021
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2026
Last update
Jan 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04833387
Collaborators
Liaoning Cancer Hospital & Institute, Fudan University
Responsible party
Pei-Rong Ding (Professor, Sun Yat-sen University) — Principal investigator
First posted
Apr 6, 2021
Start date
Jan 1, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 11, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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