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Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms

ConditionPancreatic Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must voluntarily participate in the study and sign the informed consent form.

Aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.

Diagnosed with pancreatic ductal adenocarcinoma through histological or cytological confirmation.

Have at least one evaluable metastatic lesion according to RECIST 1.1 criteria;

Disqualifiers

Subjects with a history of or concurrent diagnosis of other malignant tumors within the past 5 years.

Unresolved toxicities from prior treatments exceeding Grade 1 according to Common Terminology Criteria (CTC) AE criteria, excluding alopecia.

Major surgical procedures, significant traumatic injuries, or unhealed wounds or fractures within 28 days prior to the first dose.

Any bleeding or hemorrhagic event of ≥ Grade 3 according to CTC AE criteria within 4 weeks prior to the first dose.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TQB2868 injection

    Drug

    TQB2868 injection is an anti-PD 1/growth factor (GF)-β Receptor Type II (TGF-βRII) bifunctional fusion protein.

  • Gemcitabine injection

    Drug

    Gemcitabine injection

  • Albumin paclitaxel injection

    Drug

    Albumin paclitaxel injection

  • Anlotinib capsules

    Drug

    Anlotinib capsules

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsulesExperimental treatment 4 interventions
Group B: TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injectionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

The time between the start of treatment and tumorigenesis (in any aspect) progression or death (due to any cause). The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days).

Time frame
The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

Secondary outcomes

1

Objective Response Rate (ORR)

The proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit is the sum of the proportion of complete and partial responses.

Time frame
The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
2

Overall survival (OS)

Time from the start of treatment to death (due to any cause).

Time frame
The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
3

Duration of Response (DOR)

The period between the first diagnosis of CR or PR and the discovery of progressive disease (PD).

Time frame
The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
4

Disease Control Rate (DCR)

The percentage of cases with remission (PR+CR) and stable lesion (SD) after treatment accounted for the number of evaluable cases.

Time frame
The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

Other outcomes

Sponsors and contacts

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

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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