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Not yet recruitingNCT05640726Updated Dec 7, 2022

The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

A Phase 2 interventional study of PD-1 and SCRT in Rectal Cancer, sponsored by Fujian Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by Fujian Cancer Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases

02

Conditions studied

  • Rectal Cancer

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 30 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 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

Inclusion criteria

  • Histologically confirmed adenocarcinoma of the rectum；
  • The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis)；
  • ECOG PS 0-2；
  • CHild Pugh A；
  • Estimated survival ≥3 months;
  • Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
  • Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;
  • Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women;
  • No previous antitumor therapy；
  • No previous liver local therapy；
  • No contraception during the reproductive period;
  • patients known to have a history of allergy to any study drug, similar drug or excipient;
  • Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
  • Patients with a history of thromboembolism, except those caused by PICC;
  • Patients with active infection;
  • Other conditions that the investigator determines are not suitable for inclusion in the study.
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
    (SCRT) followed by PD-1+ standard therapy

    Drug: PD-1 · Radiation: SCRT · Drug: Bevacizumab · Drug: Oxaliplatin · Drug: Calcium folinate · Drug: 5-fluorouracil

Interventions

  • DrugPD-1

    Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

  • RadiationSCRT

    Radiotherapy dose: 5×5 Gy

  • DrugBevacizumab

    Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks

  • DrugOxaliplatin

    Participants will receive Oxaliplatin，85mg/m2，day1

  • DrugCalcium folinate

    Participants will receive calcium folinate ，400mg/m2，day1

  • Drug5-fluorouracil

    Participants will receive 5-fluorouracil ，400mg/m2，day1

06

What researchers measure

Primary outcomes

  1. progression free survival

    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

    Time frame: up to 36 months

Secondary outcomes

  1. objective response rate

    Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).

    Time frame: every 3 months (up to 36 months）

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05640726
Lead sponsor
Fujian Cancer Hospital
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
May 1, 2023 (estimated)
Primary completion
May 1, 2024 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Dec 7, 2022

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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