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Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

ConditionmCRC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJinan Central Hospital

About this trial

This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years .

Histologically confirmed unresectable colorectal adenocarcinoma.

Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance.

Documented KRAS and BRAF mutation status (mutant or wild-type) must be available.

Disqualifiers

History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment.

Radiation or systemic anticancer therapy within 14 days prior to first study treatment.

Active CNS metastases and/or leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds/fistulae.

Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis.

Trial design

Design model

Single group

Treatments tested in this trial

  • Palliative radiotherapy

    Radiation

    Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.

  • Iparomlimab and tuvonralimab

    Drug

    5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).

  • TAS-102

    Drug

    35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).

  • Bevacizumab

    Drug

    7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Experimental ArmExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

ORR

The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

Time frame
approximately 4 months after the last subject participating in

Secondary outcomes

1

PFS

the proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.

Time frame
approximately 12 months after the last subject participating in
2

OS

The time from the starting date of study drug to the date of death due to any cause.

Time frame
approximately 12 months after the last subject participating in
3

DCR

The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects

Time frame
approximately 4 months after the last subject participating in
4

Safety (adverse event)

The rates of adverse events.

Time frame
Up to approximately 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinan Central Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: