NCT05980689

Brief Summary

This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 26, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

July 26, 2023

Last Update Submit

February 5, 2024

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR) rate

    Rate of complete response (CR), including pathologic complete response (pCR) and clinical complete response (cCR).

    an average of 6 months.

Secondary Outcomes (7)

  • Adverse effects

    From date of randomization until the date of death from any cause, assessed up to 5 years

  • Rate of Major pathologic response and tumor regression grade distribution

    an average of 1 year.

  • Rate of surgical complications

    The surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 1 year from the surgery.

  • Disease free survival

    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.

  • Local recurrence free survival

    From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.

  • +2 more secondary outcomes

Study Arms (1)

Treatment Arm

EXPERIMENTAL

A total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage.

Drug: AK104Drug: CapecitabineRadiation: Neoadjuvant Radiotherapy

Interventions

AK104DRUG

During neo-CRT: 2 cycles of AK104, 10mg/kg d1 q3w. After neo-CRT: 3 cycles of AK104, 10mg/kg d1 q3w.

Also known as: Cadonilimab
Treatment Arm
CapecitabineDRUG

During neo-CRT: 825mg/m2 bid Monday-Friday per week

Treatment Arm
Neoadjuvant RadiotherapyRADIATION

IMRT DT: 50Gy/25Fx

Treatment Arm

Eligibility Criteria

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

You may qualify if:

  • Age 18-75
  • ECOG 0-1
  • Rectal adenocarcinoma
  • cT3-4aNany or cT1-4aN+
  • No distant metastasis
  • Location ≤12 cm from the anal verge
  • Positive PD-L1 expression (PD-L1 TPS≥1% or PD-L1 CPS ≥1)
  • the MSI status is MSS and pMMR
  • Sufficient bone marrow, kidney and liver function
  • No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy, no immunotherapy

You may not qualify if:

  • bowel obstruction
  • Distant metastasis
  • Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
  • Uncontrollable severe hypertesion
  • Active severe infection
  • Cachexia, organ dysfunction
  • Previous pelvic radiotherapy or chemotherapy
  • Multiple primary cancers
  • Epileptic seizures
  • Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma
  • Persons deprived of liberty or under guardianship
  • Impossibility for compliance to follow-up
  • Certain or suspicious allergy to research drug
  • Pregnant or breast-feeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

CapecitabineNeoadjuvant Therapy

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCombined Modality TherapyTherapeutics

Central Study Contacts

WeiWei Xiao

CONTACT

8613710390520xiaoww@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 8, 2023

Study Start

October 24, 2023

Primary Completion

June 30, 2024

Study Completion

January 31, 2025

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

CN(1)