Rectal CancerPhase 2NCT05640726
The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy
A Phase 2 study testing PD-1, SCRT and Bevacizumab in people with Rectal Cancer, run by Fujian Cancer Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- PD-1, SCRT and Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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
- Conditions
- Rectal Cancer
- Being tested
- PD-1, SCRT, Bevacizumab, Oxaliplatin, Calcium folinate
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1Drug
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
SCRTRadiation
Radiotherapy dose: 5×5 Gy
BevacizumabDrug
Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks
OxaliplatinDrug
Participants will receive Oxaliplatin，85mg/m2，day1
Calcium folinateDrug
Participants will receive calcium folinate ，400mg/m2，day1
5-fluorouracilDrug
Participants will receive 5-fluorouracil ，400mg/m2，day1
| Study group | Role | What they receive |
|---|---|---|
| (SCRT) followed by PD-1+ standard therapy | Experimental | Not described Receives: Drug: PD-1; Radiation: SCRT; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
Measured: up to 36 months
Secondary outcomes (1)
objective response rate
Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
Measured: every 3 months (up to 36 months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640726
- Sponsor's protocol ID
- TCO002
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy
- ClinicalTrials.gov ID
- NCT05640726
- Acronym / sponsor ID
- TCO002
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (SCRT) followed by PD-1+ standard therapy | Experimental | Drug: PD-1, Radiation: SCRT, Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Calcium folinate, Drug: 5-fluorouracil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks | Drug | (SCRT) followed by PD-1+ standard therapy |
| SCRTRadiotherapy dose: 5×5 Gy | Radiation | (SCRT) followed by PD-1+ standard therapy |
| BevacizumabParticipants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks | Drug | (SCRT) followed by PD-1+ standard therapy |
| OxaliplatinParticipants will receive Oxaliplatin，85mg/m2，day1 | Drug | (SCRT) followed by PD-1+ standard therapy |
| Calcium folinateParticipants will receive calcium folinate ，400mg/m2，day1 | Drug | (SCRT) followed by PD-1+ standard therapy |
| 5-fluorouracilParticipants will receive 5-fluorouracil ，400mg/m2，day1 | Drug | (SCRT) followed by PD-1+ standard therapy |
Primary outcome
progression free survival
Time frame: up to 36 months
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
1 secondary outcome
objective response rate
Time frame: every 3 months (up to 36 months）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1, SCRT and Bevacizumab in people with Rectal Cancer, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.